FDA.reportPublic FDA data

Application 208927

Type
ANDA
Sponsor
BIOCON LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEMETREXEDPEMETREXEDINJECTABLE;INJECTION100MGNoNo
002PEMETREXEDPEMETREXEDINJECTABLE;INJECTION500MGNoNo

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 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PemfexyPEMETREXEDAcacia Pharma, Ltd.caef07ce-066b-4c48-98dc-974b05ebbbe02026-06-18Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PemfexyPEMETREXEDEagle Pharmaceuticals, Inc.2308f4e8-21c8-49c1-a5b8-deb8610bac6a2026-02-20Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PemetrexedPEMETREXEDSolco Healthcare US, LLCbd0ada98-3237-4465-8ba2-3a12c33116fb2025-12-31Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
generic name: PEMETREXED
PemetrexedPEMETREXED DISODIUMSandoz Inc.7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab32025-12-16Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMMeitheal Pharmaceuticals Inc.e0d000a3-b9d2-4fa9-9591-f7acb077481d2025-11-17Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PEMETREXEDPEMETREXEDHospira, Inc.3ae68628-7ab0-4491-b3ae-6a8330b719c82025-10-08Warnings, Adverse reactionsName fallback
brand name: PEMETREXED
generic name: PEMETREXED
AXTLEPEMETREXEDAvyxa Pharma, LLC9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b12025-10-08Warnings, Adverse reactionsName fallback
generic name: PEMETREXED
PemetrexedPEMETREXED DISODIUMFresenius Kabi USA, LLCae77f00f-d43b-4b75-afd5-a2a9cb7138da2025-08-31Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMSomerset Therapeutics LLC39219e4b-80a6-4d4f-96a3-1202e542d0502025-05-10Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMCamber Pharmaceuticals, Inc.2ca1ce75-5284-4282-b76a-3700d203c7142025-04-01Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMShilpa Medicare Limitedfe432994-e61b-4a87-8c98-cc20b847d0fe2024-11-28Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMSagent Pharmaceuticalsfa8f1f52-3f05-4ae8-bfec-7f0a029e68252024-09-30Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMNorthStar RxLLC64f4a9ed-26ff-4bc7-bef1-4faa98b355632024-09-10Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PEMETREXEDPEMETREXEDHospira, Inc.3e087418-69ff-47fa-93c2-f286993094332024-07-24Warnings, Adverse reactionsName fallback
brand name: PEMETREXED
generic name: PEMETREXED
PEMETREXEDPEMETREXEDAccord Healthcare Inc.dfd19e67-54cb-c062-e053-2995a90a294a2024-07-18Warnings, Adverse reactionsName fallback
brand name: PEMETREXED
generic name: PEMETREXED
PemetrexedPEMETREXED DISODIUMMeitheal Pharmaceuticals Inc.1ceacc3e-f555-489b-8b16-2baa58b2f5a52024-04-19Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMMeitheal Pharmaceuticals Inc.5fb3a2d5-b9ec-4044-abb9-3e0d848a448e2024-04-19Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMWaverley Pharma Inc95633c32-89a8-4275-94e7-939c9f2e61352023-12-30Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXED DISODIUMBluePoint Laboratories4cc1574b-3d2f-489b-9ad3-55695bb972002023-10-10Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
PemetrexedPEMETREXEDBluePoint Laboratories495c6751-8d6f-4093-8108-9bed283fce032023-09-05Warnings, Adverse reactionsName fallback
brand name: Pemetrexed
generic name: PEMETREXED