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HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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 43.

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HYDROCHLORIDE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-3084e616aacf4f…
2026-08-18 06:07:402026-07N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018029-001RITALIN-SR20MGTABLET, EXTENDED RELEASE / ORALRLD1982-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018029-001RITALIN-SR20MGTABLET, EXTENDED RELEASE / ORALRLD1982-03-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-303f01610625f2…
2019-09-15 20:21 UTC2019-09N018029-001RITALIN-SR20MGTABLET, EXTENDED RELEASE / ORALRLD1982-03-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N018029-001RITALIN-SR20MGTABLET, EXTENDED RELEASE / ORALRLD1982-03-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-303a93d1ddd44b…
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…

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 2 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate Hydrochloride Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC9e11e093-4ff3-4bed-8fe9-3ee460b473032025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METADATE CDMETHYLPHENIDATE HYDROCHLORIDEAytu BioPharma, Inc.be59f8b4-7842-42cc-9559-bfa747f0baa52025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack9beb136f-020b-4631-b989-c1d26a9846f72025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochlorideMETHYLPHENIDATE HYDROCHLORIDEActavis Pharma, Inc.ecbb4a30-21ac-42e1-b4e9-6c35344ffc452025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAmerican Health Packagingeb9b7377-d918-43fb-8e82-d14c85ed64a82025-10-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEGranules Pharmaceuticals Inc.27ea91ad-f64e-43d7-ab10-6f988bca53792025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLCed004cf0-eb23-43d2-96dc-20c4ad63824f2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
JORNAY PM Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDEIronshore Pharmaceuticals Inc.d95dede0-b1ff-4489-8f91-3bbe122852bf2025-10-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride (LA)METHYLPHENIDATE HYDROCHLORIDEDr. Reddy's Laboratories Incd8c14df4-ac05-d69d-9308-58a51d5683292025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
RELEXXIIMETHYLPHENIDATE HYDROCHLORIDEVertical Pharmaceuticals, LLC22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d2025-09-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDETrigen Laboratories, LLCdd8d7b6e-c23d-4e16-bb53-959e9127ebc62025-09-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Ritalin LAMETHYLPHENIDATE HYDROCHLORIDENovartis Pharmaceuticals Corporationeffd952d-ac94-47bb-b107-589a4934dcca2025-09-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate hydrochlorideMETHYLPHENIDATE HYDROCHLORIDESolco Healthcare US,LLC238ff743-4f25-43a3-87ac-6559d12a9d492025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical Inc778190da-1528-4def-94bf-ee23ee5268a52025-08-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack5a22dd9b-9b48-4c96-8b20-0d20131521dc2025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack1c7d7e6c-4e96-4d18-8dca-203ef50766ec2025-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDERising Pharma Holdings, Inc.e5cb0740-813f-4dce-8c29-d7680c66e77c2025-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESun Pharmaceutical Industries, Inc.1a89b390-0cd5-45cb-9e70-20de44652c562025-02-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCc614cf55-b462-4f7e-b19c-6d22a47e509f2025-02-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
RitalinMETHYLPHENIDATE HYDROCHLORIDESandoz Incd6fb2750-cdab-4749-ba0d-7534840a58922025-02-05Boxed 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