METHYLPHENIDATE HYDROCHLORIDE - Food and Drug Administration

Set ID
fd4d0878-dcea-3832-288e-e3bbbbe580ff
Type
Indexing - Product Concept
Effective date
2024-05-16
Version
9
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 1955Product nameGranules Pharmaceuticals Inc.2026-10-08
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameNorthstar Rx LLC | Ohm Laboratories Inc.2026-08-27
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA) safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA). METHYLPHENIDATE HYDROCHLORIDE extended-release capsules (LA) for oral use, CII Initial U.S. Approval: 1955Product nameMayne Pharma | Sharp Corporation2026-08-24
Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameGranules Pharmaceuticals Inc.2026-08-18
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameSun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.2026-08-17
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets for oral use, CII Initial U.S. Approval: 1955Product nameAurolife Pharma, LLC | JANSSEN PHARMACEUTICALS, INC.2026-08-13
Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameGolden State Medical Supply, Inc. | Granules Pharmaceuticals Inc.2026-08-11
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules CD, CII Initial U.S. Approval: 1955Product nameLannett Company, LLC2026-07-31
Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameGranules Pharmaceuticals Inc.2026-07-17
These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Capsules safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Capsules Methylphenidate Hydrochloride Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1955Product nameRhodes Pharmaceuticals LLC | Patheon Manufacturing Services LLC | Knoa Pharmaceuticals LLC2026-05-29
These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Capsules safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Capsules Methylphenidate Hydrochloride Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1955Product nameRhodes Pharmaceuticals LLC | Patheon Manufacturing Services LLC | Knoa Pharmaceuticals LLC2026-05-29
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameLannett Company, Inc.2026-05-28
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 1955Product nameAmneal Pharmaceuticals of New York LLC | Amneal Pharmaceuticals of New York, LLC2026-05-27
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION, CII Initial U.S. Approval: 1955Product nameKVK-Tech, Inc. | ABHAI, LLC.2026-05-11
These highlights do not include all the information needed to use METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS. METHYLPHENIDATE hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameLannett Company, Inc.2026-05-01
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameActavis Pharma, Inc.2026-04-30
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameSun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.2026-04-29
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameSun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.2026-04-24
These highlights do not include all the information needed to use methylphenidate hydrochloride extended-release tablets USP safely and effectively. See full prescribing information for METHYLPHENIDATE hydrochloride extended-release tablets USP. METHYLPHENIDATE hydrochloride extended-release tablets USP, for oral use, CII Initial U.S. Approval: 2000Product nameTrigen Laboratories, LLC2026-04-24
METHYLPHENIDATE hydrochloride extended-release tablets USP. These highlights do not include all the information needed to use methylphenidate hydrochloride extended-release tablets USP safely and effectively. See full prescribing information for METHYLPHENIDATE hydrochloride extended-release tablets USP. METHYLPHENIDATE hydrochloride extended-release tablets USP, for oral use, CII Initial U.S. Approval: 2000Product nameGolden State Medical Supply, Inc. | Osmotica Pharmaceutical US LLC2026-04-23
Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameGolden State Medical Supply, Inc. | Granules Pharmaceuticals Inc.2026-04-23
These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA ® (methylphenidate hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameJanssen Pharmaceuticals, Inc. | AndersonBrecon Inc. | Janssen Ortho LLC | Janssen-Cilag Manufacturing, LLC2026-04-20
These highlights do not include all the information needed to use QUILLICHEW ER ® safely and effectively. See full prescribing information for QUILLICHEW ER ® . QUILLICHEW ER ® (methylphenidate hydrochloride) extended-release chewable tablets , for oral use, CII Initial U.S. Approval: 1955Product nameNextWave Pharmaceuticals, Inc2026-04-08
These highlights do not include all the information needed to use QUILLICHEW ER ® safely and effectively. See full prescribing information for QUILLICHEW ER ® . QUILLICHEW ER ® (methylphenidate hydrochloride) extended-release chewable tablets , for oral use, CII Initial U.S. Approval: 1955Product nameNextWave Pharmaceuticals, Inc2026-04-08
These highlights do not include all the information needed to use QUILLICHEW ER ® safely and effectively. See full prescribing information for QUILLICHEW ER ® . QUILLICHEW ER ® (methylphenidate hydrochloride) extended-release chewable tablets , for oral use, CII Initial U.S. Approval: 1955Product nameNextWave Pharmaceuticals, Inc2026-04-08
These highlights do not include all the information needed to use QUILLICHEW ER ® safely and effectively. See full prescribing information for QUILLICHEW ER ® . QUILLICHEW ER ® (methylphenidate hydrochloride) extended-release chewable tablets , for oral use, CII Initial U.S. Approval: 1955Product nameNextWave Pharmaceuticals, Inc2026-04-07
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameNorthstar Rx LLC | Ohm Laboratories Inc.2026-04-02
These highlights do not include all the information needed to use QUILLIVANT XR ® safely and effectively. See full prescribing information for QUILLIVANT XR ® . QUILLIVANT XR ® (methylphenidate hydrochloride) for extended-release oral suspension, CII Initial U.S. Approval: 1955Product nameNextWave Pharmaceuticals, Inc2026-03-24
These highlights do not include all the information needed to use QUILLIVANT XR ® safely and effectively. See full prescribing information for QUILLIVANT XR ® . QUILLIVANT XR ® (methylphenidate hydrochloride) for extended-release oral suspension, CII Initial U.S. Approval: 1955Product nameNextWave Pharmaceuticals, Inc2026-03-20
Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameGranules Pharmaceuticals Inc.2026-03-17
These highlights do not include all the information needed to use METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS. METHYLPHENIDATE hydrochloride extended-release tablets, USP for oral use CII Initial U.S. Approval: 2000Product nameBryant Ranch Prepack2026-03-17
These highlights do not include all the information needed to use METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS. METHYLPHENIDATE hydrochloride extended-release tablets, USP for oral use CII Initial U.S. Approval: 2000Product nameBryant Ranch Prepack2026-03-17
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameSun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.2026-03-13
These highlights do not include all the information needed to use COTEMPLA XR-ODT safely and effectively. See full prescribing information for COTEMPLA XR-ODT. COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets), CII Initial U.S. Approval: 1955Product nameNeos Therapeutics Brands, LLC | Aphena Pharma Solutions | Halo Pharmaceuticals, Inc.2026-03-02
These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA ® (methylphenidate hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameJanssen Pharmaceuticals, Inc. | AndersonBrecon Inc. | Janssen Ortho LLC | Janssen-Cilag Manufacturing, LLC2026-02-27
These highlights do not include all the information needed to use QUILLICHEW ER ® safely and effectively. See full prescribing information for QUILLICHEW ER ® . QUILLICHEW ER ® (methylphenidate hydrochloride) extended-release chewable tablets , for oral use, CII Initial U.S. Approval: 1955Product nameNextWave Pharmaceuticals, Inc2026-02-25
These highlights do not include all the information needed to use methylphenidate hydrochloride extended-release tablets USP safely and effectively. See full prescribing information for METHYLPHENIDATE hydrochloride extended-release tablets USP. METHYLPHENIDATE hydrochloride extended-release tablets USP, for oral use, CII Initial U.S. Approval: 2000Product nameTrigen Laboratories, LLC2026-02-16
Methylphenidate Hydrochloride Extended-Release Tablets, USP CII Rx Only These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. Initial U.S. Approval: 2000Product nameAvPAK2026-01-08
Methylphenidate Hydrochloride Tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. Initial U.S. Approval: 1955Product nameAvPAK2026-01-08
These highlights do not include all the information needed to use METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS. METHYLPHENIDATE hydrochloride extended-release tablets, USP for oral use CII Initial U.S. Approval: 2000Product nameLannett Company, Inc.2026-01-06
These highlights do not include all the information needed to use Methylphenidate Hydrochloride Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Tablets USP CII. Methylphenidate hydrochloride tablets, for oral use, CII Initial U.S. Approval: 1955Product nameKVK-TECH, INC. | Abhai, LLC2026-01-02
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameAmerican Health Packaging2025-12-04
These highlights do not include all the information needed to use METHYLPHENIDATE HCl EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HCl EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HCl extended-release capsules, CII Initial U.S. Approval: 1955Product nameSpecGx LLC2025-12-01
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION, CII Initial U.S. Approval: 1955Product nameKVK-Tech, Inc. | ABHAI, LLC.2025-11-24
These highlights do not include all the information needed to use Methylphenidate Hydrochloride Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Tablets USP CII. Methylphenidate hydrochloride tablets, for oral use, CII Initial U.S. Approval: 1955Product nameKVK-TECH, INC. | ABHAI, LLC2025-11-24
These highlights do not include all the information needed to use METADATE CD ® safely and effectively. See full prescribing information for METADATE CD. METADATE CD (methylphenidate hydrochloride) extended-release capsules, CII Initial U.S. Approval: 1955Product nameAytu BioPharma, Inc.2025-11-18
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2025-11-11
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA) safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA). METHYLPHENIDATE HYDROCHLORIDE extended-release capsules (LA) for oral use, CII Initial U.S. Approval: 1955Product nameMayne Pharma | Sharp Corporation2025-11-06
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 1955Product nameActavis Pharma, Inc.2025-10-31
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameAmerican Health Packaging2025-10-22
Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameGranules Pharmaceuticals Inc.2025-10-14
These highlights do not include all the information needed to use methylphenidate hydrochloride extended-release tablets USP safely and effectively. See full prescribing information for METHYLPHENIDATE hydrochloride extended-release tablets USP. METHYLPHENIDATE hydrochloride extended-release tablets USP, for oral use CII Initial U.S. Approval: 2000Product nameTrigen Laboratories, LLC2025-10-14
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 1955Product nameGranules Pharmaceuticals Inc.2025-10-08
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameSpecGx LLC2025-10-08
These highlights do not include all the information needed to use METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HCl extended-release tablets, for oral use CII Initial U.S. Approval: 2000Product nameAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC2025-10-07
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 1955Product nameAmneal Pharmaceuticals of New York LLC | Amneal Pharmaceuticals of New York, LLC2025-10-07
These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameKVK-Tech, Inc. | ABHAI LLC2025-10-07
These highlights do not include all the information needed to use METHYLPHENIDATE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for METHYLPHENIDATE TRANSDERMAL SYSTEM. METHYLPHENIDATE transdermal system Initial U.S. Approval: 2006Product nameMylan Pharmaceuticals Inc.2025-10-07
These highlights do not include all the information needed to use METHYLPHENIDATE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for METHYLPHENIDATE TRANSDERMAL SYSTEM. METHYLPHENIDATE transdermal system Initial U.S. Approval: 2006Product nameMylan Pharmaceuticals Inc.2025-10-07
These highlights do not include all the information needed to use JORNAY PM® safely and effectively. See full prescribing information for JORNAY PM. JORNAY PM (methylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 1955Product nameIronshore Pharmaceuticals Inc. | Patheon Puerto Rico, Inc.2025-10-03
These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Capsules safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Capsules Methylphenidate Hydrochloride Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1955Product nameRhodes Pharmaceuticals | Patheon Manufacturing Services LLC | Purdue Pharmaceuticals L.P.2025-10-01
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA) safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA). METHYLPHENIDATE HYDROCHLORIDE extended-release capsules (LA) for oral use, CII Initial U.S. Approval: 1955Product nameDr. Reddy's Laboratories Inc2025-09-30
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules CD, CII Initial U.S. Approval: 1955Product nameLannett Company, Inc.2025-09-30
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules CD, CII Initial U.S. Approval: 1955Product nameLannett Company, Inc.2025-09-30
These highlights do not include all the information needed to use QUILLIVANT XR ® safely and effectively. See full prescribing information for QUILLIVANT XR ® . QUILLIVANT XR ® (methylphenidate hydrochloride) for extended-release oral suspension, CII Initial U.S. Approval: 1955Product nameNextWave Pharmaceuticals, Inc2025-09-30
These highlights do not include all the information needed to use methylphenidate hydrochloride extended-release tablets safely and effectively. See full prescribing information for methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets for oral use, CII Initial U.S. Approval: 2000Product nameTrigen Laboratories, LLC2025-09-26
These highlights do not include all the information needed to use RELEXXII ® safely and effectively. See full prescribing information for RELEXXII ® . RELEXXII ® (methylphenidate hydrochloride extended-release tablets) for oral use, CII Initial U.S. Approval: 2000Product nameVertical Pharmaceuticals, LLC2025-09-26
These highlights do not include all the information needed to use METHYLPHENIDATE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for METHYLPHENIDATE TRANSDERMAL SYSTEM. Methylphenidate Transdermal System, CII Initial U.S. Approval: 2006Product namePADAGIS US LLC | NOVEN PHARMACEUTICALS, INC.2025-09-25
These highlights do not include all the information needed to use COTEMPLA XR-ODT safely and effectively. See full prescribing information for COTEMPLA XR-ODT. COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets), CII Initial U.S. Approval: 1955Product nameNeos Therapeutics Brands, LLC | Aphena Pharma Solutions | Halo Pharmaceuticals, Inc.2025-09-24
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules for oral use, CII Initial U.S. Approval: 1955Product nameSandoz Inc2025-09-23
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules for oral use, CII Initial U.S. Approval: 1955Product nameSandoz Inc2025-09-23
These highlights do not include all the information needed to use RITALIN LA safely and effectively. See full prescribing information for RITALIN LA. RITALIN LA ® (methylphenidate hydrochloride) extended-release capsules for oral use, CII Initial U.S. Approval: 1955Product nameNovartis Pharmaceuticals Corporation2025-09-23
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. Methylphenidate hydrochloride tablets, for oral use, CII Initial U.S. Approval: 1955Product nameSolco Healthcare US,LLC | Prinston Pharmaceutical Inc. | Generics Bidco ⅡLLC2025-09-18
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA) safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA). METHYLPHENIDATE HYDROCHLORIDE extended-release capsules (LA) for oral use, CII Initial U.S. Approval: 1955Product nameMayne Pharma | Sharp Corporation2025-09-04
These highlights do not include all the information needed to use DAYTRANA ® safely and effectively. See full prescribing information for DAYTRANA. DAYTRANA ® (methylphenidate transdermal system), CII Initial U.S. Approval: 2006Product nameNoven Therapeutics, LLC | Noven Pharmaceuticals, Inc.2025-09-01
These highlights do not include all the information needed to use COTEMPLA XR-ODT safely and effectively. See full prescribing information for COTEMPLA XR-ODT. COTEMPLA XR-ODT (methylphenidate extended-release orally disintegrating tablets), CII Initial U.S. Approval: 1955Product nameNeos Therapeutics Brands, LLC | Aphena Pharma Solutions | Halo Pharmaceuticals, Inc.2025-08-21
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameCamber Pharmaceutical Inc | Ascent pharmaceutical Inc2025-08-06
Methylphenidate hydrochloride extended-release tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameGranules Pharmaceuticals Inc.2025-07-15
Methlyphenidate Hydrochloride Tablets, USP CII These highlights do not include all the information needed to use Methlyphenidate Hydrochloride Tablet safely and effectively. See full prescribing information for Methlyphenidate Hydrochloride Tablet. Initial U.S. Approval: 1955Product nameAurolife Pharma, LLC | JANSSEN PHARMACEUTICALS, INC.2025-06-03
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2025-04-01
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2025-03-17
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE Chewable Tablets s afely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE Chewable Tablets . METHYLPHENIDATE HYDROCHLORIDE Chewable Tablets (Methylphenidate hydrochloride), for oral use, CII Initial U.S. Approval: 1955Product nameRising Pharma Holdings, Inc. | Tedor Pharma Inc.2025-03-12
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameSun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc.2025-02-27
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameAmneal Pharmaceuticals of New York LLC | Amneal Pharmaceuticals of New York, LLC | Johnson Matthey Inc.2025-02-19
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameNeolpharma, Inc.2025-02-12
These highlights do not include all the information needed to use RITALIN safely and effectively. See full prescribing information for RITALIN. RITALIN ® (methylphenidate hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 1955Product nameNovartis Pharmaceuticals Corporation2025-02-05
These highlights do not include all the information needed to use RITALIN safely and effectively. See full prescribing information for RITALIN. RITALIN ® (methylphenidate hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 1955Product nameSandoz Inc2025-02-05
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION . METHYLPHENIDATE HYDROCHLORIDE Oral Solution, CII Initial U.S. Approval: 1955Product nameCranbury Pharmaceuticals, LLC2025-01-30
These highlights do not include all the information needed to use METHYLPHENIDATE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for METHYLPHENIDATE TRANSDERMAL SYSTEM. METHYLPHENIDATE transdermal system Initial U.S. Approval: 2006Product nameMylan Pharmaceuticals Inc.2025-01-27
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameNorthstar Rx LLC | Ohm Laboratories Inc.2025-01-20
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA) safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (LA). METHYLPHENIDATE HYDROCHLORIDE extended-release capsules (LA) for oral use, CII Initial U.S. Approval: 1955Product nameDr. Reddy's Laboratories Inc2024-12-05
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 1955Product nameGranules Pharmaceuticals Inc.2024-12-04
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-11-18
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-11-18
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-11-18
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-10-31
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS and METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS and METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameAmerican Health Packaging2024-10-08
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameSpecGx LLC2024-09-01
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameSpecGx LLC2024-09-01
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameAscend Laboratories, LLC | Alkem Laboratories Limited2024-07-15
These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955Product nameKVK-Tech, Inc. | ABHAI LLC2024-06-20
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameAccord Healthcare, Inc. | WES Pharma Inc.2024-06-18
These highlights do not include all the information needed to use methylphenidate hydrochloride extended-release tablets USP safely and effectively. See full prescribing information for METHYLPHENIDATE hydrochloride extended-release tablets USP. METHYLPHENIDATE hydrochloride extended-release tablets USP, for oral use CII Initial U.S. Approval: 2000Product nameTrigen Laboratories, LLC2024-06-12
These highlights do not include all the information needed to use METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HCl EXTENDED-RELEASE TABLETS. METHYLPHENIDATE HCl extended-release tablets, for oral use CII Initial U.S. Approval: 2000Product nameAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC2024-05-15
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION . METHYLPHENIDATE HYDROCHLORIDE Oral Solution, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-04-03
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION . METHYLPHENIDATE HYDROCHLORIDE Oral Solution, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-04-03
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE oral solution safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE oral solution. METHYLPHENIDATE HYDROCHLORIDE oral solution, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-04-03
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-04-03
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-04-03
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-04-03
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameActavis Pharma, Inc.2024-04-02
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE oral solution safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE oral solution. METHYLPHENIDATE HYDROCHLORIDE oral solution, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-04-02
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameActavis Pharma, Inc.2024-04-01
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METHYLPHENIDATE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 2000Product nameActavis Pharma, Inc.2024-04-01
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules for oral use, CII Initial U.S. Approval: 1955Product nameSandoz Inc2024-03-29
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameLupin Pharmaceuticals,Inc. | Novel Laboratories, Inc.2024-03-21
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. METHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules for oral use, CII Initial U.S. Approval: 1955Product nameSandoz Inc2024-02-28
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955Product nameNivagen Pharmaceuticals, Inc.2024-02-26
Methylphenidate HCl Chewable Tablet, CII Rx onlyProduct nameBryant Ranch Prepack2024-02-05
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE oral solution safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE oral solution. METHYLPHENIDATE HYDROCHLORIDE oral solution, CII Initial U.S. Approval: 1955Product nameBryant Ranch Prepack2024-02-05