AMANTADINE HYDROCHLORIDE - Food and Drug Administration

Set ID
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721
Type
Indexing - Product Concept
Effective date
2022-02-24
Version
2
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameSupernus Pharmaceuticals, Inc.2026-10-05
These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameAdamas Pharma, LLC2026-10-05
These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameSupernus Pharmaceuticals, Inc.2026-09-08
These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameAdamas Pharma, LLC2026-09-08
Amantadine Hydrochloride Capsules, USP 8442201/0526F Rx onlyProduct nameAmerican Health Packaging2026-06-23
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameA-S Medication Solutions2026-05-15
Amantadine Hydrochloride Capsules USP Rx onlyProduct nameBryant Ranch Prepack2026-04-15
Amantadine Hydrochloride Oral Solution USP 50 mg/5 mLProduct nameCardinal Health 107, LLC2026-04-08
Amantadine Hydrochloride TabletsProduct nameZhejiang Jutai Pharmaceutical Co., Ltd. | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.2026-03-26
These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameSupernus Pharmaceuticals2026-02-16
Amantadine Hydrochloride Tablets, USP Rx onlyProduct nameProficient Rx LP2026-02-01
Amantadine Hydrochloride Capsules USP Rx onlyProduct nameStrides Pharma Inc. | Strides Pharma Science Limited | Strides Alathur Private Limited2026-01-30
Amantadine Hydrochloride Tablets, USP Rx onlyProduct nameNCS HealthCare of KY, LLC dba Vangard Labs2026-01-23
Amantadine Hydrochloride Oral Solution, USP 50 mg/5 mL Rx onlyProduct nameAvPAK2026-01-19
Amantadine HCLProduct nameDirect RX2026-01-15
Rx onlyProduct nameMajor Pharmaceuticals2026-01-05
Amantadine Hydrochloride Oral Solution, USPProduct nameChartwell Governmental & Specialty RX, LLC.2025-12-19
Amantadine Hydrochloride Oral Solution, USPProduct nameChartwell RX, LLC2025-12-12
Amantadine Hydrochloride TabletsProduct nameStrides Pharma Inc. | Strides Pharma Science Limited | Strides Alathur Private Limited2025-12-12
Amantadine Hydrochloride Tablets, USPProduct nameUpsher-Smith Laboratories, LLC | BORA Pharmaceuticals, Inc.2025-12-11
Amantadine Hydrochloride Capsules USP Rx onlyProduct nameStrides Pharma Inc. | Strides Pharma Science Limited | Strides Alathur Private Limited2025-12-05
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameBryant Ranch Prepack2025-10-24
Rx onlyProduct nameBryant Ranch Prepack2025-10-22
Rx onlyProduct nameBryant Ranch Prepack2025-10-22
These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameSupernus Pharmaceuticals2025-10-22
These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameAdamas Pharma, LLC2025-10-22
Amantadine Hydrochloride Capsules-TabletsProduct nameMarlex Pharmaceuticals Inc2025-09-10
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameST. MARY'S MEDICAL PARK PHARMACY2025-09-02
GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameSupernus Pharmaceuticals2025-08-15
GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968Product nameAdamas Pharma, LLC2025-08-15
Amantadine Hydrochloride Oral Solution USP 50 mg/5 mLProduct namePAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma2025-08-07
AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mLProduct nameATLANTIC BIOLOGICALS CORP.2025-07-31
Amantadine Hydrochloride Tablets, USP Rx onlyProduct nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2025-07-28
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameBryant Ranch Prepack2025-07-14
AMANTADINE HYDROCHLORIDE CAPSULES, USPProduct nameUpsher-Smith Laboratories, LLC | Accucaps Industries Limited2025-07-09
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameAdvagen Pharma Limited | Rubicon Research Limited2025-07-09
Amantadine Hydrochloride Oral Solution USP 50 mg /5 mL 16 ozProduct nameBAJAJ MEDICAL, LLC2025-07-02
Rx onlyProduct nameBryant Ranch Prepack2025-06-26
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameAvPAK2025-06-24
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameAvKARE2025-06-24
Amantadine Hydrochloride Tablets Rx onlyProduct nameActavis Pharma, Inc.2025-06-10
Amantadine Hydrochloride Capsules, USP Rx OnlyProduct nameBionpharma Inc. | Patheon Softgels Inc.2025-06-09
Amantadine Hydrochloride Capsules, USPProduct nameEPIC PHARMA LLC | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd2025-06-06
Rx onlyProduct nameHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.2025-06-06
Amantadine Hydrochloride Capsules, USPProduct nameRising Pharma Holdings, Inc. | InvaTech Pharma Solutions LLC2025-06-04
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2025-06-04
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameZydus Lifesciences Limited2025-06-04
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited2025-06-04
Amantadine 16oz, 10mL Lid, InsertProduct nameXttrium Laboratories, Inc | Xttrium Laboratories, Inc.2025-05-21
Amantadine Hydrochloride Oral Solution USP 50 mg/5 mLProduct nameATLANTIC BIOLOGICALS CORP.2025-05-12
Amantadine Hydrochloride Tablets, USP Rx onlyProduct nameCoupler LLC2025-03-13
Amantadine Hydrochloride TabletsProduct nameCoupler LLC2025-02-07
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameBryant Ranch Prepack2025-02-05
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameProficient Rx LP2025-02-01
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameCoupler LLC | Zydus Pharmaceuticals (USA) Inc.2025-01-27
Amantadine HCLProduct nameDirect_Rx2025-01-22
Rx onlyProduct nameBryant Ranch Prepack2024-11-04
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameChartwell RX, LLC2024-10-10
Amantadine Hydrochloride Capsules, USP 8442201/0724 Rx onlyProduct nameAmerican Health Packaging2024-08-14
Rx onlyProduct nameNCS HealthCare of KY, LLC dba Vangard Labs2024-08-05
Amantadine Hydrochloride Oral Solution, USPProduct namePatrin Pharma, Inc.2024-05-20
AMANTADINE HYDROCHLORIDE- amantadine hydrochloride capsuleProduct nameAPNAR PHARMA LP | InvaTech Pharma Solutions LLC2024-03-09
AMANTADINE HYDROCHLORIDE- amantadine hydrochloride tabletProduct nameApnar Pharma LP | InvaTech Pharma Solutions LLC2024-03-09
Amantadine HCLProduct nameDirect_Rx2024-02-29
Amantadine Hydrochloride Oral Solution USP I0646C0124 R01/24 Rx onlyProduct nameAmerican Health Packaging2024-02-21
Amantadine Hydrochloride Capsules, USP Rx OnlyProduct nameStrides Pharma Science Limited2023-07-17
Amantadine Hydrochloride Capsules USP Rx onlyProduct nameRPK Pharmaceuticals, Inc.2023-06-07
Amantadine Hydrochloride CapsuleProduct nameATHEM LLC | InvaTech Pharma Solutions LLC2023-03-21
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameAlembic Pharmaceuticals Limited2023-01-27
Amantadine Hydrochloride Tablets Rx onlyProduct nameAlembic Pharmaceuticals Limited2023-01-27
Amantadine Hydrochloride Oral Solution, USPProduct nameAkorn | Akorn Operating Company LLC2022-09-13
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameProficient Rx LP2022-09-01
AMANTADINE HYDROCHLORIDE TABLETProduct nameAthem LLC | InvaTech Pharma Solutions2021-02-19
Amantadine hydrochlorideProduct nameBLUEBAY SHANDONG CO.,LTD2019-12-02
Amantadine Hydrochloride Capsules USP Rx onlyProduct nameProficient Rx LP2019-10-01
Amantadine Hydrochloride Tablets, 100mg Rx onlyProduct nameGraviti Pharmaceuticals Private Limited | suven life sciences | Moehs Catalana S.L2019-02-08
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameGraviti Pharmaceuticals Private Limited | suven life sciences | Moehs Catalana S.L2019-02-07
AX Pharmaceutical Corp bulk ingredientProduct nameAX Pharmaceutical Corp2018-06-04
Amantadine Hydrochloride Oral Solution USP 50 mg/5 mLProduct nameUnit Dose Services2018-04-11
NewGen Pharmaceuticals LLC human prescription drug labelProduct nameNewGen Pharmaceuticals LLC2017-02-09
NewGen Pharmaceuticals LLC human prescription drug labelProduct nameNewGen Pharmaceuticals LLC2017-01-15
Amantadine Hydrochloride Capsules, USPProduct nameCarilion Materials Management2016-08-04
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameBanner Life Sciences LLC. | Banner Pharmacaps Inc2015-09-08
Amantadine Hydrochloride Capsules, USPProduct nameAphena Pharma Solutions - Tennessee, LLC2014-06-10
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameState of Florida DOH Central Pharmacy2014-02-26
Amantadine Hydrochloride Capsules, USPProduct namePhysicians Total Care, Inc.2014-01-17
Amantadine Hydrochloride Capsules, USPProduct nameAidarex Pharmaceuticals LLC2013-11-15
AMANTADINE HCLProduct nameBryant Ranch Prepack | Banner Pharmacaps Inc.2012-10-12
Amantadine Hydrochloride Oral Solution USP 50 mg/5 mLProduct nameCarilion Materials Management2012-08-29
Amantadine Hydrochloride Capsules, USP Rx onlyProduct nameBanner Pharmacaps Inc2012-07-12
Physicians Total Care, Inc. human prescription drug labelProduct namePhysicians Total Care, Inc.2010-11-17
Amantadine Hydrochloride Capsules, USPProduct nameSTAT RX USA LLC2010-09-16
Rebel Distributors Corp. human prescription drug labelProduct nameRebel Distributors Corp.2010-09-02