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Generated: November 15, 2018

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Details for New Drug Application (NDA): 021790

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NDA 021790 describes DACOGEN, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the DACOGEN profile page.

The generic ingredient in DACOGEN is decitabine. There are eighteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 021790
Applicant:Otsuka Pharm Co Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 021790
Suppliers and Packaging for NDA: 021790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DACOGEN decitabine INJECTABLE;INTRAVENOUS 021790 NDA Otsuka America Pharmaceutical, Inc. 59148-046 59148-046-70 1 VIAL in 1 CARTON (59148-046-70) > 20 mL in 1 VIAL
DACOGEN decitabine INJECTABLE;INTRAVENOUS 021790 NDA Eisai Inc. 62856-600 62856-600-01 1 VIAL in 1 CARTON (62856-600-01) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/VIAL
Approval Date:May 2, 2006TE:APRLD:Yes

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