FDA.reportPublic FDA data

Application 074047

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIDOVUDINEZIDOVUDINECAPSULE; ORAL100MGNoNo

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 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZidovudineZIDOVUDINECoupler LLC437f55b2-f6d9-0065-e063-6294a90ab9292026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zidovudine
generic name: ZIDOVUDINE
ZidovudineZIDOVUDINEAurobindo Pharma Limited51abd2ce-6be1-412d-b806-5f24935ac5e32025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zidovudine
generic name: ZIDOVUDINE
ZidovudineZIDOVUDINEAurobindo Pharma Limited9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf2025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zidovudine
generic name: ZIDOVUDINE
RETROVIRZIDOVUDINEViiV Healthcare Company6df09f15-b102-431c-adde-d7aeef6f5d842024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIDOVUDINE
ZidovudineZIDOVUDINEAurobindo Pharma Limitede7c8ddef-005d-4f1c-8c1a-ea84044ab4d42024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zidovudine
generic name: ZIDOVUDINE
ZidovudineZIDOVUDINECamber Pharmaceuticals, Inc.ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f42023-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zidovudine
generic name: ZIDOVUDINE

Reported adverse events (FAERS/openFDA)#

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