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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 214408

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NDA 214408 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, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, and Sandoz, and is included in twenty-three NDAs. It is available from twenty-two 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-four suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.

Summary for 214408

Tradename:	PEMETREXED DISODIUM
Applicant:	Accord Hlthcare
Ingredient:	pemetrexed disodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 214408

Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date:	Jul 19, 2022	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)
Approval Date:	Jul 19, 2022	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)
Approval Date:	Jul 19, 2022	TE:		RLD:	Yes

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