FDA.reportPublic FDA data

Application 071426

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VINCASAR PFSVINCRISTINE SULFATEINJECTABLE;INJECTION1MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A071426-001VINCASAR PFSVINCRISTINE SULFATE1MG/MLINJECTABLE / INJECTION1987-07-17

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A071426-001VINCASAR PFS1MG/MLINJECTABLE / INJECTION1987-07-17a50c72e98297…

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 · 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
generic name: VINCRISTINE SULFATE
VinCRIStine SulfateVINCRISTINE SULFATEHospira, Inc.49596de6-ab18-49d1-9e5b-30968fc21c362025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VINCRISTINE SULFATE