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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 090384


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NDA 090384 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, Norvium Bioscience, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, and Sandoz, and is included in twenty-three NDAs. It is available from twenty 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 090384
Tradename:PEMETREXED DISODIUM
Applicant:Fresenius Kabi Usa
Ingredient:pemetrexed disodium
Patents:0
Pharmacology for NDA: 090384
Suppliers and Packaging for NDA: 090384
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 090384 ANDA Fresenius Kabi USA, LLC 63323-134 63323-134-10 1 VIAL, SINGLE-USE in 1 CARTON (63323-134-10) / 4 mL in 1 VIAL, SINGLE-USE
PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 090384 ANDA Fresenius Kabi USA, LLC 63323-450 63323-450-50 1 VIAL, SINGLE-USE in 1 CARTON (63323-450-50) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 100MG BASE/VIAL
Approval Date:May 25, 2022TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:May 25, 2022TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 750MG BASE/VIAL
Approval Date:May 25, 2022TE:APRLD:No

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