FDA.reportPublic FDA data

Application 078815

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS50MG/VIALNoNo
002OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS100MG/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
A078815-001OXALIPLATINOXALIPLATIN50MG/VIALINJECTABLE / INTRAVENOUS2009-09-30
A078815-002OXALIPLATINOXALIPLATIN100MG/VIALINJECTABLE / INTRAVENOUS2009-09-30

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 22:54:322026-06A078815-001OXALIPLATIN50MG/VIALINJECTABLE / INTRAVENOUS2009-09-30a50c72e98297…
2026-08-01 22:54:322026-06A078815-002OXALIPLATIN100MG/VIALINJECTABLE / INTRAVENOUS2009-09-30a50c72e98297…

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxaliplatinOXALIPLATINShandong New Time Pharmaceutical Co., Ltd.1ac38523-480b-4c0f-97a1-7dfa1432923c2026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINNorthStar Rx LLCf299b2d2-86ed-4fb8-822e-65455a0bb75a2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINNorthstar Rx LLC7dc8dfb1-dec8-43b3-b2ea-05eac054b2c62026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINCamber Pharmaceuticals, Inc.b0799e39-7b1e-430a-b159-062b395210012025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
oxaliplatinOXALIPLATINSagent Pharmaceuticals29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f2025-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINMylan Institutional LLCda0e8523-609a-4326-96b1-d7de78662d912025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINBluePoint Laboratoriesb6083405-9b45-4d2c-e053-2995a90ad9ef2025-02-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINQilu Pharmaceutical Co., Ltd.33d4f4b4-bb4e-46af-9e89-df20154436d02024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINMeitheal Pharmaceuticals Inc.11377169-7986-45b1-8298-6f0533efa3c32024-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINHospira, Inc.e51a62ba-d163-4c57-835c-8c86cf097e402024-09-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINMeitheal Pharmaceuticals Inc.ee2e0da9-5ae7-405b-8dd1-635be72bc4392024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINApotex Corp.ee5a5a1d-63f6-4d5a-901b-65be45ec66102024-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINApotex Corp.bb180ec5-1f75-43c1-9f63-c0657af2ca5f2024-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINEugia US LLC1bb4febd-0ed4-48c9-ba2a-e22183a2143f2024-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINMeitheal Pharmaceuticals Inc.7e38318e-c569-4ad4-8f10-a235f30444d12024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINMeitheal Pharmaceuticals Inc.873fa936-157a-4f85-bc70-5df31d71d1222024-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
oxaliplatinOXALIPLATINAccord Healthcare Inc.4b805925-beb1-2bac-e054-00144ff88e882024-01-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: oxaliplatin
generic name: OXALIPLATIN
OXALIPLATINOXALIPLATINWinthrop U.S, a business of sanofi-aventis U.S. LLC70269278-fe61-4800-a064-32cb6845cc282023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXALIPLATIN
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINFOSUN PHARMA USA INC.fad0f147-6595-4412-87a7-2afca0192a962023-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN
OxaliplatinOXALIPLATINGland Pharma Limiteda6f89dc3-a594-4b5b-8728-272e20c1ecb52023-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaliplatin
generic name: OXALIPLATIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43147ORIG2013-04-23