FDA.reportPublic FDA data

Application 077389

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS50MG/5ML (10MG/ML)NoNo
002CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS150MG/15ML (10MG/ML)NoNo
003CARBOPLATINCARBOPLATININJECTABLE;INTRAVENOUS450MG/45ML (10MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077389-001CARBOPLATINCARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2007-03-30
A077389-002CARBOPLATINCARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2007-03-30
A077389-003CARBOPLATINCARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2007-03-30

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 22:54:322026-06A077389-001CARBOPLATIN50MG/5ML (10MG/ML)INJECTABLE / INTRAVENOUS2007-03-30a50c72e98297…
2026-08-01 22:54:322026-06A077389-002CARBOPLATIN150MG/15ML (10MG/ML)INJECTABLE / INTRAVENOUS2007-03-30a50c72e98297…
2026-08-01 22:54:322026-06A077389-003CARBOPLATIN450MG/45ML (10MG/ML)INJECTABLE / INTRAVENOUS2007-03-30a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARBOPLATINCARBOPLATINBPI Labs LLC5484d2f0-0cc2-4bba-8f26-c7f6539a96062025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBOPLATIN
generic name: CARBOPLATIN
KYXATACARBOPLATINAvyxa Pharma, LLCf91c48da-68d1-4aa7-89b8-d84a3e8b629b2025-09-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CarboplatinCARBOPLATINAccord Healthcare, Inc.48aa7ef3-9f44-2a08-e054-00144ff88e882025-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carboplatin
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINEugia US LLC5abfcb87-bb02-4384-9c9d-7d0e3e8093112025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBOPLATIN
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINEugia US LLCf5fe9a20-47a5-45b9-ab06-c6158d9b6aca2025-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBOPLATIN
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINTeyro Labs Private Limitedf64a0cbe-7fe3-407e-8933-21c30e1a1ebc2025-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBOPLATIN
generic name: CARBOPLATIN
CarboplatinCARBOPLATINHospira, Inc.47677091-fd20-49af-933c-c9dd2be21de92024-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carboplatin
generic name: CARBOPLATIN
CarboplatinCARBOPLATINHospira, Inc.c3ae9880-44bb-4f4e-93d8-8a5e21708a302024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carboplatin
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINApotex Corp.1c275825-0275-4c73-b650-e4c1519f13b82024-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBOPLATIN
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINGland Pharma Limited9eb057eb-29ce-40d2-9ac8-ed107f25f5ab2023-11-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBOPLATIN
generic name: CARBOPLATIN
CarboplatinCARBOPLATINTeva Parenteral Medicines, Inc.e176b6ef-2ff6-498b-a9d8-7a634d147f372022-08-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carboplatin
generic name: CARBOPLATIN
CarboplatinCARBOPLATINFresenius Kabi USA, LLCb4fa7aac-c9d2-4af4-a281-3e6cfc502ff62021-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Carboplatin
generic name: CARBOPLATIN
CARBOplatinCARBOPLATINTeva Parenteral Medicines, Inc.f330f5a2-2cad-402f-bcbb-26245a7532762016-01-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CARBOplatin
generic name: CARBOPLATIN