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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205582

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NDA 205582 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla Ltd, Dr Reddys Labs Ltd, Pharmascience Inc, Sagent Pharms, Sandoz Inc, and Sun Pharma Global, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DECITABINE profile page.

The generic ingredient in DECITABINE is decitabine. There are seventeen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 205582
Applicant:Sun Pharma Global
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205582
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DECITABINE decitabine POWDER;INTRAVENOUS 205582 NDA Sun Pharma Global FZE 47335-361 N 47335-361-41

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength50MG/VIAL
Approval Date:Jan 28, 2014TE:RLD:Yes

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