FDA.reportPublic FDA data

Application 065033

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BLEOMYCIN SULFATEBLEOMYCIN SULFATEINJECTABLE;INJECTIONEQ 15 UNITS BASE/VIALNoNo
002BLEOMYCIN SULFATEBLEOMYCIN SULFATEINJECTABLE;INJECTIONEQ 30 UNITS BASE/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065033-001BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2000-06-27
A065033-002BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTION2000-06-27

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 22:54:322026-06A065033-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2000-06-27a50c72e98297…
2026-08-01 22:54:322026-06A065033-002BLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTION2000-06-27a50c72e98297…

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
BleomycinBLEOMYCIN SULFATEMeitheal Pharmaceuticals Inc.640602f9-a7df-46f0-a9b1-19c471008bee2026-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BLEOMYCIN SULFATE
BleomycinBLEOMYCIN SULFATEFresenius Kabi USA, LLCb5806c40-12ce-48e3-8abd-9f8997ef44282024-10-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BLEOMYCIN SULFATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-3154BleomycinBleomycinTeva Parenteral Medicines, Inc.ANDACurrent
0703-3154BleomycinBleomycinTeva Parenteral Medicines, Inc.ANDACurrent
0703-3155BleomycinBleomycinTeva Parenteral Medicines, Inc.ANDACurrent
0703-3155BleomycinBleomycinTeva Parenteral Medicines, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8375ORIG2000-06-27