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Generated: May 23, 2017

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Details for New Drug Application (NDA): 201784

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NDA 201784 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: 201784

Formulation / Manufacturing:see details

Pharmacology for NDA: 201784

Suppliers and Packaging for NDA: 201784

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 201784 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0155 0069-0155-01 20 mL in 1 VIAL (0069-0155-01)
INJECTABLE;INJECTION 201784 ANDA Mylan Institutional LLC 67457-452 67457-452-20 1 VIAL in 1 CARTON (67457-452-20) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jan 30, 2012TE:APRLD:No

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