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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
McKesson
QuintilesIMS
Cantor Fitzgerald
Moodys
Johnson and Johnson
Express Scripts
Accenture
Fish and Richardson

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207518

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NDA 207518 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 fourteen 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 207518
Tradename:AZACITIDINE
Applicant:Shilpa Medicare
Ingredient:azacitidine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207518
Medical Subject Heading (MeSH) Categories for 207518
Suppliers and Packaging for NDA: 207518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZACITIDINE azacitidine POWDER;IV (INFUSION), SUBCUTANEOUS 207518 ANDA Dr. Reddy's Laboratories Inc. 43598-678 N 43598-678-11
AZACITIDINE azacitidine POWDER;IV (INFUSION), SUBCUTANEOUS 207518 ANDA Fresenius Kabi USA, LLC 63323-771 N 63323-771-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION), SUBCUTANEOUSStrength100MG/VIAL
Approval Date:Sep 29, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cerilliant
AstraZeneca
Chubb
Deloitte
Julphar
Teva
Mallinckrodt
UBS

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