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Details for New Drug Application (NDA): 200914

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NDA 200914 describes CYTARABINE, which is a drug marketed by Fresenius Kabi Usa, Mylan Labs Ltd, Mylan Pharms Inc, Hospira, West-ward Pharms Int, and Teva Parenteral, and is included in thirteen 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. Six suppliers are listed for this compound. Additional details are available on the cytarabine profile page.

Summary for NDA: 200914

Mylan Labs Ltd

Pharmacology for NDA: 200914

Suppliers and Packaging for NDA: 200914

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 200914 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0154 0069-0154-01 50 mL in 1 VIAL (0069-0154-01)
INJECTABLE;INJECTION 200914 ANDA Mylan Institutional LLC 67457-454 67457-454-50 50 mL in 1 VIAL (67457-454-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Dec 13, 2011TE:APRLD:No

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