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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 209775


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NDA 209775 describes CLOFARABINE, which is a drug marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hospira, Meitheal, MSN, Mylan Labs Ltd, and Novast Labs, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the CLOFARABINE profile page.

The generic ingredient in CLOFARABINE is clofarabine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
Summary for 209775
Tradename:CLOFARABINE
Applicant:Msn
Ingredient:clofarabine
Patents:0
Pharmacology for NDA: 209775
Suppliers and Packaging for NDA: 209775
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 209775 ANDA Apotex Corp. 60505-6166 60505-6166-0 1 VIAL, SINGLE-USE in 1 CARTON (60505-6166-0) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/20ML (1MG/ML)
Approval Date:Dec 6, 2017TE:APRLD:No

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