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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 209085

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NDA 209085 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 nineteen 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 209085

Tradename:	PEMETREXED DISODIUM
Applicant:	Apotex
Ingredient:	pemetrexed disodium
Patents:	0

Pharmacology for NDA: 209085

Mechanism of Action	Folic Acid Metabolism Inhibitors

Medical Subject Heading (MeSH) Categories for 209085

Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 209085

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	209085	ANDA	BluePoint Laboratories	68001-546	68001-546-41	1 VIAL in 1 CARTON (68001-546-41) / 40 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 1GM BASE/VIAL
Approval Date:	May 25, 2022	TE:	AP	RLD:	No

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