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Last Updated: July 11, 2020

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Details for New Drug Application (NDA): 208216

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NDA 208216 describes AZACITIDINE, which is a drug marketed by Accord Hlthcare, Actavis Llc, Cipla, Dr Reddys, Lupin Ltd, Mylan Institutional, Natco Pharma Ltd, and Shilpa Medicare, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the AZACITIDINE profile page.

The generic ingredient in AZACITIDINE is azacitidine. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
Summary for 208216
Applicant:Actavis Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 208216
Medical Subject Heading (MeSH) Categories for 208216
Suppliers and Packaging for NDA: 208216
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 208216 NDA BluePoint Laboratories 68001-313 68001-313-56 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68001-313-56)

Profile for product number 001

Approval Date:Apr 29, 2016TE:APRLD:No

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