Details for New Drug Application (NDA): 203131

NDA 203131 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 203131

Tradename:	DECITABINE
Applicant:	Dr Reddys
Ingredient:	decitabine
Patents:	0

Pharmacology for NDA: 203131

Mechanism of Action

Nucleic Acid Synthesis Inhibitors

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) / 10 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) / 10 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Jul 11, 2013	TE:	AP	RLD:	No

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