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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 208601

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NDA 208601 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, MSN, Nivagen Pharms Inc, Novast Labs, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty NDAs. It is available from twenty-four suppliers. Additional details are available on the DECITABINE profile page.

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

Summary for 208601

Tradename:	DECITABINE
Applicant:	Cipla
Ingredient:	decitabine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Nov 16, 2017	TE:		RLD:	No

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