Last Updated: September 28, 2026

Details for New Drug Application (NDA): 021790

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NDA 021790 describes DACOGEN, which is a drug marketed by Otsuka and is included in one NDA. Additional details are available on the DACOGEN profile page.

The generic ingredient in DACOGEN is decitabine. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the decitabine profile page.

Summary for 021790

Tradename:	DACOGEN
Applicant:	Otsuka
Ingredient:	decitabine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 2, 2006	TE:		RLD:	Yes

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