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Serving leading biopharmaceutical companies globally:

Harvard Business School
Argus Health

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204949

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NDA 204949 describes AZACITIDINE, which is a drug marketed by Actavis Llc, Dr Reddys Labs Ltd, Mylan Institutional, Natco Pharma Ltd, and Shilpa Medicare, and is included in five NDAs. It is available from eight suppliers. Additional details are available on the AZACITIDINE profile page.

The generic ingredient in AZACITIDINE is azacitidine. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
Summary for 204949
Applicant:Mylan Institutional
Formulation / Manufacturing:see details
Pharmacology for NDA: 204949
Medical Subject Heading (MeSH) Categories for 204949
Suppliers and Packaging for NDA: 204949
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZACITIDINE azacitidine POWDER;IV (INFUSION), SUBCUTANEOUS 204949 ANDA Mylan Institutional LLC 67457-254 N 67457-254-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION), SUBCUTANEOUSStrength100MG/VIAL
Approval Date:Apr 28, 2016TE:APRLD:No

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