BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Argus Health
Cerilliant
Cantor Fitzgerald
Novartis
Colorcon
Daiichi Sankyo
Julphar
Citi

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200915

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NDA 200915 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 200915
Tradename:CYTARABINE
Applicant:Mylan Labs Ltd
Ingredient:cytarabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200915
Medical Subject Heading (MeSH) Categories for 200915
Suppliers and Packaging for NDA: 200915
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYTARABINE cytarabine INJECTABLE;INJECTION 200915 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0152 0069-0152-02 10 VIAL in 1 CARTON (0069-0152-02) > 5 mL in 1 VIAL (0069-0152-01)
CYTARABINE cytarabine INJECTABLE;INJECTION 200915 ANDA Mylan Institutional LLC 67457-455 67457-455-52 10 VIAL in 1 CARTON (67457-455-52) > 5 mL in 1 VIAL (67457-455-00)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

UBS
Baxter
Harvard Business School
Covington
Fish and Richardson
Boehringer Ingelheim
Medtronic
McKinsey
QuintilesIMS

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