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Serving leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Fish and Richardson
Argus Health
Boehringer Ingelheim

Generated: December 14, 2017

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, Dr Reddys Labs Ltd, Pharmascience Inc, Sandoz Inc, and Sun Pharma Global, and is included in six NDAs. It is available from five suppliers. Additional details are available on the DECITABINE profile page.

The generic ingredient in DECITABINE is decitabine. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the decitabine profile page.

Summary for 203131

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 43598-348-37 1 VIAL, SINGLE-USE in 1 CARTON (43598-348-37) > 50 mL in 1 VIAL, SINGLE-USE
DECITABINE decitabine INJECTABLE;INTRAVENOUS 203131 ANDA Dr.Reddy's Laboratories Inc 43598-427 43598-427-37 1 VIAL, SINGLE-USE in 1 CARTON (43598-427-37) > 50 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Farmers Insurance
US Department of Justice

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