FDA.reportPublic FDA data

Application 019880

Type
NDA
Sponsor
CORDEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PARAPLATINCARBOPLATININJECTABLE;INJECTION50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002PARAPLATINCARBOPLATININJECTABLE;INJECTION150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003PARAPLATINCARBOPLATININJECTABLE;INJECTION450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N019880-001PARAPLATINCARBOPLATIN50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-03-03
N019880-002PARAPLATINCARBOPLATIN150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-03-03
N019880-003PARAPLATINCARBOPLATIN450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-03-03

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 22:54:322026-06N019880-001PARAPLATIN50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-03-03a50c72e98297…
2026-08-01 22:54:322026-06N019880-002PARAPLATIN150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-03-03a50c72e98297…
2026-08-01 22:54:322026-06N019880-003PARAPLATIN450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1989-03-03a50c72e98297…

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
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
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINEugia US LLC5abfcb87-bb02-4384-9c9d-7d0e3e8093112025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINEugia US LLCf5fe9a20-47a5-45b9-ab06-c6158d9b6aca2025-01-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINTeyro Labs Private Limitedf64a0cbe-7fe3-407e-8933-21c30e1a1ebc2025-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CarboplatinCARBOPLATINHospira, Inc.47677091-fd20-49af-933c-c9dd2be21de92024-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CarboplatinCARBOPLATINHospira, Inc.c3ae9880-44bb-4f4e-93d8-8a5e21708a302024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINApotex Corp.1c275825-0275-4c73-b650-e4c1519f13b82024-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CARBOPLATINCARBOPLATINGland Pharma Limited9eb057eb-29ce-40d2-9ac8-ed107f25f5ab2023-11-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CarboplatinCARBOPLATINTeva Parenteral Medicines, Inc.e176b6ef-2ff6-498b-a9d8-7a634d147f372022-08-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CarboplatinCARBOPLATINFresenius Kabi USA, LLCb4fa7aac-c9d2-4af4-a281-3e6cfc502ff62021-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN
CARBOplatinCARBOPLATINTeva Parenteral Medicines, Inc.f330f5a2-2cad-402f-bcbb-26245a7532762016-01-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CARBOPLATIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19788SUPPL2010-11-12
1747SUPPL2002-02-14
41074SUPPL1998-01-06