FDA.reportPublic FDA data

Application 071222

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VINCRISTINE SULFATEVINCRISTINE SULFATEInjectable; Injection1MG/VIALNoNo

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VinCRIStine SulfateVINCRISTINE SULFATEHospira, Inc.b22e4c8e-dbe1-4d4b-a026-e1812974071c2026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VinCRIStine Sulfate
generic name: VINCRISTINE SULFATE
VinCRIStine SulfateVINCRISTINE SULFATEHospira, Inc.49596de6-ab18-49d1-9e5b-30968fc21c362025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VinCRIStine Sulfate
generic name: VINCRISTINE SULFATE

Reported adverse events (FAERS/openFDA)#

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