FDA.reportPublic FDA data

Application 089311

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VINBLASTINE SULFATEVINBLASTINE SULFATEInjectable; Injection1MG/MLNoNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vinblastine SulfateVINBLASTINE SULFATEFresenius Kabi USA, LLCf073b58e-56d6-4c8d-a2ce-b37719402d772025-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Vinblastine Sulfate
generic name: VINBLASTINE SULFATE

Reported adverse events (FAERS/openFDA)#

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