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Serving leading biopharmaceutical companies globally:

Dow
Fuji
Medtronic
QuintilesIMS
Healthtrust
Accenture
Federal Trade Commission
Express Scripts
Cantor Fitzgerald
Harvard Business School

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076512

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NDA 076512 describes CYTARABINE, which is a drug marketed by Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Mylan Pharms Inc, Sagent Pharms, Teva Parenteral, and West-ward Pharms Int, and is included in fourteen 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 076512
Tradename:CYTARABINE
Applicant:Fresenius Kabi Usa
Ingredient:cytarabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076512
Medical Subject Heading (MeSH) Categories for 076512
Suppliers and Packaging for NDA: 076512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYTARABINE cytarabine INJECTABLE;INJECTION 076512 ANDA Fresenius Kabi USA, LLC 63323-120 63323-120-20 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) > 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jan 15, 2004TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Julphar
Boehringer Ingelheim
Medtronic
Farmers Insurance
Baxter
Cipla
Teva
AstraZeneca

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