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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 071868


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NDA 071868 describes CYTARABINE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Norvium Bioscience, Rising, Teva Parenteral, and West-ward Pharms Int, and is included in nineteen NDAs. It is available from five suppliers. Additional details are available on the CYTARABINE profile page.

The generic ingredient in CYTARABINE is cytarabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cytarabine profile page.
Summary for 071868
Tradename:CYTARABINE
Applicant:Hospira
Ingredient:cytarabine
Patents:0
Pharmacology for NDA: 071868
Medical Subject Heading (MeSH) Categories for 071868
Suppliers and Packaging for NDA: 071868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYTARABINE cytarabine INJECTABLE;INJECTION 071868 ANDA Hospira, Inc. 61703-305 61703-305-38 5 VIAL, SINGLE-DOSE in 1 CARTON (61703-305-38) / 5 mL in 1 VIAL, SINGLE-DOSE (61703-305-58)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Jun 4, 1990TE:APRLD:No

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