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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215179


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NDA 215179 describes PEMETREXED, which is a drug marketed by Avyxa Holdings, 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, Norvium Bioscience, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, and Sandoz, and is included in twenty-seven NDAs. It is available from four 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 twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed ditromethamine profile page.
Summary for 215179
Tradename:PEMETREXED
Applicant:Shilpa
Ingredient:pemetrexed disodium
Patents:1
Pharmacology for NDA: 215179
Suppliers and Packaging for NDA: 215179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEMETREXED pemetrexed disodium SOLUTION;INTRAVENOUS 215179 NDA SHILPA MEDICARE LIMITED 63759-3048 63759-3048-1 1 VIAL in 1 CARTON (63759-3048-1) / 10 mL in 1 VIAL
PEMETREXED pemetrexed disodium SOLUTION;INTRAVENOUS 215179 NDA SHILPA MEDICARE LIMITED 63759-3049 63759-3049-1 1 VIAL in 1 CARTON (63759-3049-1) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 100MG/10ML BASE (10MG/ML)
Approval Date:May 22, 2023TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 26, 2035Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 500MG/50ML BASE (10MG/ML)
Approval Date:May 22, 2023TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 26, 2035Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 1GM/100ML BASE (10MG/ML)
Approval Date:May 22, 2023TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 26, 2035Product Flag?YSubstance Flag?Delist Request?

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