FDA.reportPublic FDA data

Application 211090

Type
NDA
Sponsor
BIOCON PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEMETREXED DISODIUMPEMETREXED DISODIUMPOWDER;INTRAVENOUSEQ 100MG BASE/VIALNoNo

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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PemetrexedPEMETREXED DISODIUMSandoz Inc.7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab32025-12-16Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMMeitheal Pharmaceuticals Inc.e0d000a3-b9d2-4fa9-9591-f7acb077481d2025-11-17Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMFresenius Kabi USA, LLCae77f00f-d43b-4b75-afd5-a2a9cb7138da2025-08-31Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PEMRYDI RTUPEMETREXED DISODIUMAmneal Pharmaceuticals LLC0f006b06-ab85-423d-ba0c-dfc3fc25844e2025-07-08Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMSomerset Therapeutics LLC39219e4b-80a6-4d4f-96a3-1202e542d0502025-05-10Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMCamber Pharmaceuticals, Inc.2ca1ce75-5284-4282-b76a-3700d203c7142025-04-01Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMShilpa Medicare Limitedfe432994-e61b-4a87-8c98-cc20b847d0fe2024-11-28Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMSagent Pharmaceuticalsfa8f1f52-3f05-4ae8-bfec-7f0a029e68252024-09-30Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMNorthStar RxLLC64f4a9ed-26ff-4bc7-bef1-4faa98b355632024-09-10Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMMeitheal Pharmaceuticals Inc.1ceacc3e-f555-489b-8b16-2baa58b2f5a52024-04-19Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMMeitheal Pharmaceuticals Inc.5fb3a2d5-b9ec-4044-abb9-3e0d848a448e2024-04-19Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMWaverley Pharma Inc95633c32-89a8-4275-94e7-939c9f2e61352023-12-30Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMBluePoint Laboratories4cc1574b-3d2f-489b-9ad3-55695bb972002023-10-10Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
AlimtaPEMETREXED DISODIUMEli Lilly and Companyf5a860f3-37ec-429c-ae04-9c88d7c55c082023-05-19Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMBluePoint Laboratories61588f3c-4c06-4c35-a000-201dd10190932023-04-26Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMBluePoint Laboratories14974d4e-2f01-4e02-aea2-c28b3ca0781c2023-04-26Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMMeitheal Pharmaceuticals Inc.b185f459-5489-4e18-8521-1686b5d16f672022-12-21Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
PemetrexedPEMETREXED DISODIUMBluePoint Laboratoriesc9f34c00-1176-4f44-8cff-bae5bdc0c40f2022-12-08Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM
Pemetrexed disodiumPEMETREXED DISODIUMDr. Reddys Laboratories Inc1d8bcf03-e055-a274-7844-ae9a523e3c4c2022-09-30Warnings, Adverse reactionsName fallback
brand name: Pemetrexed disodium
generic name: PEMETREXED DISODIUM
pemetrexedPEMETREXED DISODIUMZydus Pharmaceuticals USA Inc.363665ca-db15-4123-84ac-0ae66b5f13632022-05-26Warnings, Adverse reactionsName fallback
generic name: PEMETREXED DISODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70377-022PemetrexedPemetrexed disodiumBiocon Pharma IncANDACurrent