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HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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HYDROCHLORIDE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-3084e616aacf4f…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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30caaa826d4ba7…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UTC2026-02N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-30011fe1cb6892…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of this ZIP2025-12N018029-001RITALIN-SR20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1982-03-3031067a03dcf5…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 4 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.57fd619e-687d-403c-a77a-3dc3a1bab65a2023-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.5bfe50ed-171f-4c40-bc0b-20c68e8e20252023-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEEywa Pharma Inc298fb86d-7d94-49e1-b743-3e78011224222023-11-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
MethylinMETHYLPHENIDATE HYDROCHLORIDESHIONOGI INC.9e3c22d9-71d9-46a7-b315-8021c94c4bec2023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC981a2ad8-33f7-4678-9162-9df9685bd4a62023-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.91833146-fa95-471a-8b8d-6d36a2db5c9a2023-09-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e02023-09-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC59de488c-c3f8-415d-9e9f-9102c090aac82023-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAscend Laboratories, LLC5fa3da25-13aa-4ee3-acf5-cd505f4688d02021-12-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEDr.Reddys Laboratories Inc7124df7e-6273-a68d-6e35-dc06122d86862021-12-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals Inc94dc74d4-b4ef-45bc-b502-54ec692e9bd52021-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals, Inc.b9af3104-172d-4975-9301-b9fe7db9ef122021-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.b07150db-fd99-4400-bb83-b3a7544a917a2021-08-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAscent Pharmaceuticals, Inc.45ebb59c-9603-4df6-b1be-3295ba2db1e72021-01-29Warnings, 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