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Daiichi Sankyo
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Generated: May 22, 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, Hong Kong, Hospira, Mylan Labs Ltd, Teva Parenteral, and West-ward Pharms Int, and is included in fourteen NDAs. It is available from four 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 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 N 63323-120-20

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 hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Colorcon
Argus Health
Queensland Health
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Dow
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