FDA.reportPublic FDA data

Application 078943

Type
ANDA
Sponsor
PLIVA LACHEMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXALIPLATINOXALIPLATININJECTABLE; INJECTION5MG/MLNoNo

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 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