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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 215460


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NDA 215460 describes PEMETREXED DISODIUM, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, and Sandoz, and is included in twenty-three NDAs. It is available from twenty suppliers. Additional details are available on the PEMETREXED DISODIUM profile page.

The generic ingredient in PEMETREXED DISODIUM is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.
Summary for 215460
Tradename:PEMETREXED DISODIUM
Applicant:Hetero Labs Ltd Vi
Ingredient:pemetrexed disodium
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 100MG BASE/VIAL
Approval Date:Jun 14, 2024TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 14, 2024TE:APRLD:No

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