FDA.reportPublic FDA data

Application 021968

Type
NDA
Sponsor
CPPI CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUTENTSUNITINIB MALATECAPSULE; ORALEQ 12.5MG BASENoNo
002SUTENTSUNITINIB MALATECAPSULE; ORALEQ 25MG BASENoNo
003SUTENTSUNITINIB MALATECAPSULE; ORALEQ 50MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog.

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 1 ยท 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunitinib malateSUNITINIB MALATENorthStar RxLLC7579e3d0-2de6-4239-a7a8-118ed92075f52026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE
SUTENTSUNITINIB MALATEPfizer Laboratories Div Pfizer Inc43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c2026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SUTENT
generic name: SUNITINIB MALATE
Sunitinib MalateSUNITINIB MALATEAvKARE0772eb61-ca42-39de-e063-6294a90a66322026-01-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE
SUNITINIB MALATESUNITINIB MALATEAurobindo Pharma Limited810dfcb2-d35b-4971-887c-2e78e82e9e072025-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE
Sunitinib MalateSUNITINIB MALATENovadoz Pharmaceuticals LLC15dd0555-b33f-4f56-94d3-0f4ce888df012025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE
Sunitinib MalateSUNITINIB MALATETeva Pharmaceuticals USA, Inc.a9479e5f-914f-46ca-95c1-327c66457e472025-01-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE
Sunitinib malateSUNITINIB MALATESun Pharmaceutical Industries Inc.06e0ad28-6637-4f54-879c-2c194aece5fd2024-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE
Sunitinib MalateSUNITINIB MALATENovugen Pharma (USA) LLC.04d34bce-1296-d2b9-e063-6394a90a70182024-09-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE
Sunitinib MalateSUNITINIB MALATEMylan Pharmaceuticals Inc.4dbfcc02-dacc-4f0c-9f41-095783b68e272023-08-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE
SUNITINIB MALATESUNITINIB MALATEDr.Reddys Laboratories Inc96ce8850-b5ae-382b-8433-04949533af442022-03-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SUNITINIB MALATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
28936SUPPL2007-02-12
28935SUPPL2007-02-12
28934SUPPL2007-02-12
6551SUPPL2007-02-12
6550SUPPL2007-02-12
37963SUPPL2007-02-05
37962SUPPL2007-02-05
16652SUPPL2007-02-05
16651SUPPL2007-02-05
16650SUPPL2007-02-05
42365SUPPL2007-02-02
42364SUPPL2007-02-02
21889SUPPL2007-02-02
21888SUPPL2007-02-02
21887SUPPL2007-02-02
42363ORIG2006-04-06
6549ORIG2006-01-30
37961ORIG2006-01-26