FDA.reportPublic FDA data

Application 018029

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RITALIN-SRMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018029-001RITALIN-SRMETHYLPHENIDATE HYDROCHLORIDE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLC768bf181-d0d8-49e5-9c87-cacbb069e0b22026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEGranules Pharmaceuticals Inc.45d33807-88b2-4b42-9c86-e5b05d7adec12026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.18024571-4505-6d51-e063-6294a90a19722026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAurolife Pharma, LLC35be77db-fbe3-487e-a220-a08a11aaec282026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEGolden State Medical Supply, Inc.98be5c84-b348-6b8e-e053-2995a90ae4cc2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride CDMETHYLPHENIDATE HYDROCHLORIDELannett Company, LLCe45c75dc-d381-475b-b649-a871c8a36e602026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METADATE CDMETHYLPHENIDATE HYDROCHLORIDELannett Company, LLC29f06562-6b6a-4ca6-b62e-d08a45fb3dd42026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELannett Company, Inc.44737c1d-fe75-409e-8a58-591696d3d7aa2026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC10aa0dc0-bd0e-4927-a19a-8722d78ad67d2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
MethylphenidateMETHYLPHENIDATE HYDROCHLORIDEKVK-Tech, Inc.2cf1b26b-199d-4c7f-ab64-4805a9def2cc2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELannett Company, Inc.3d1f5aff-5d39-496c-b5ed-7f3c70ec641c2026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEActavis Pharma, Inc.85ef422d-af27-4126-9841-6892af1871d62026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDETrigen Laboratories, LLCc45dc1de-adfa-4b3c-a7dc-cffbc8eac74f2026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEGolden State Medical Supply, Inc.22e5ddfa-7264-fbb1-e063-6394a90a64832026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
CONCERTAMETHYLPHENIDATE HYDROCHLORIDEJanssen Pharmaceuticals, Inc.1a88218c-5b18-4220-8f56-526de1a276cd2026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Quillivant XRMETHYLPHENIDATE HYDROCHLORIDENextWave Pharmaceuticals, Incc2dc2109-44a6-4797-b04e-18761dd9d45a2026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepackcd2c1226-fa19-4734-b62d-89fea73dcb0d2026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack5a29687b-5294-4b27-a556-514b092a877d2026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEKVK-TECH, INC.1bf37f9f-29cf-4b09-9c81-eb369e35a0422026-01-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmerican Health Packagingf6581305-cd1e-4171-8c1b-e184c7bde0332025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60990SUPPL2019-11-20
60989SUPPL2019-11-20
60983SUPPL2019-11-20
57267SUPPL2019-01-18
57266SUPPL2019-01-18
57188SUPPL2019-01-11
57187SUPPL2019-01-11
57186SUPPL2019-01-11
57185SUPPL2019-01-11
46826SUPPL2017-01-13
46825SUPPL2017-01-13
46706SUPPL2017-01-06
11125SUPPL2015-04-21
799SUPPL2015-04-21
33401SUPPL2013-12-17
13987SUPPL2013-12-16
13986SUPPL2013-06-11
11124SUPPL2013-06-11
798SUPPL2010-12-15
11123SUPPL2010-12-10
797SUPPL2010-11-18
33400SUPPL2010-11-17
44018ORIG2007-05-10
33399SUPPL2007-05-01
796SUPPL2007-05-01
13985SUPPL2006-08-11
795SUPPL2006-08-11
33398SUPPL2006-08-09
11122SUPPL2006-08-09
793SUPPL2004-05-27
792SUPPL2004-05-27
794SUPPL2002-01-11