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Last Updated: July 19, 2024

Details for New Drug Application (NDA): 214218


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NDA 214218 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, Hospira, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Nang Kuang Pharm Co, Prinston Inc, Qilu Pharm Hainan, Waverley Pharma Inc, Zydus Pharms, and Sandoz, and is included in twenty-two NDAs. It is available from seventeen 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. Nineteen suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.
Summary for 214218
Tradename:PEMETREXED DISODIUM
Applicant:Hospira
Ingredient:pemetrexed disodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214218
Suppliers and Packaging for NDA: 214218
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEMETREXED DISODIUM pemetrexed disodium SOLUTION;INTRAVENOUS 214218 NDA Hospira, Inc. 0409-0004 0409-0004-04 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0004-04) / 40 mL in 1 VIAL, SINGLE-DOSE
PEMETREXED DISODIUM pemetrexed disodium SOLUTION;INTRAVENOUS 214218 NDA Hospira, Inc. 0409-0020 0409-0020-02 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0020-02) / 4 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 100MG BASE/4ML (EQ 25MG BASE/ML)
Approval Date:Jun 22, 2022TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 500MG BASE/20ML (EQ 25MG BASE/ML)
Approval Date:Jun 22, 2022TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date:Jun 22, 2022TE:RLD:Yes

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