Last Updated: November 8, 2026

Details for New Drug Application (NDA): 208419

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NDA 208419 describes PEMETREXED, which is a drug marketed by Actavis, Shilpa, 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, Somerset Theraps Llc, Zydus Pharms, and Sandoz, and is included in twenty-six NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the PEMETREXED profile page.

The generic ingredient in PEMETREXED is pemetrexed ditromethamine. There are three drug master file entries for this compound. Additional details are available on the pemetrexed ditromethamine profile page.
Summary for 208419
Tradename:PEMETREXED
Applicant:Actavis
Ingredient:pemetrexed
Patents:0
Pharmacology for NDA: 208419
Mechanism of ActionFolic Acid Metabolism Inhibitors
Suppliers and Packaging for NDA: 208419
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEMETREXED pemetrexed SOLUTION;INTRAVENOUS 208419 NDA Teva Pharmaceuticals, Inc. 0480-4514 0480-4514-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4514-01) / 20 mL in 1 VIAL, SINGLE-DOSE
PEMETREXED pemetrexed SOLUTION;INTRAVENOUS 208419 NDA Teva Pharmaceuticals, Inc. 0480-4515 0480-4515-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4515-01) / 40 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/4ML (25MG/ML)
Approval Date:Aug 21, 2020TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength500MG/20ML (25MG/ML)
Approval Date:Aug 21, 2020TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1GM/40ML (25MG/ML)
Approval Date:Aug 21, 2020TE:RLD:Yes

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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