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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203131

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NDA 203131 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla Ltd, Dr Reddys Labs Ltd, Pharmascience Inc, Sandoz Inc, and Sun Pharma Global, and is included in seven NDAs. It is available from seven 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. Nine suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 203131
Applicant:Dr Reddys Labs Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 203131
Suppliers and Packaging for NDA: 203131
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DECITABINE decitabine INJECTABLE;INTRAVENOUS 203131 ANDA Dr.Reddy's Laboratories Inc 43598-348 N 43598-348-37
DECITABINE decitabine INJECTABLE;INTRAVENOUS 203131 ANDA Dr.Reddy's Laboratories Inc 43598-427 N 43598-427-37

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/VIAL
Approval Date:Jul 11, 2013TE:APRLD:No

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