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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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