Details for New Drug Application (NDA): 091280

NDA 091280 describes DESMOPRESSIN ACETATE, which is a drug marketed by Am Regent, Bedford, Dr Reddys, Gland, Gland Pharma Ltd, Hospira, Meitheal, Sagent Pharms Inc, Sun Pharm Inds Ltd, UBI, Sun Pharm Inds, Bausch, Abhai Llc, Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma, Ferring, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Natco Pharma Usa, Novast Labs, Apotex, Sun Pharm, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from twenty-two suppliers. Additional details are available on the DESMOPRESSIN ACETATE profile page.

The generic ingredient in DESMOPRESSIN ACETATE is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.

Summary for 091280

Tradename:	DESMOPRESSIN ACETATE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	desmopressin acetate
Patents:	0

Pharmacology for NDA: 091280

Physiological Effect

Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Suppliers and Packaging for NDA: 091280

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	091280	ANDA	Sun Pharmaceutical Industries, Inc.	62756-529	62756-529-26	1 VIAL, MULTI-DOSE in 1 CARTON (62756-529-26) / 10 mL in 1 VIAL, MULTI-DOSE
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	091280	ANDA	Sun Pharmaceutical Industries, Inc.	62756-529	62756-529-40	1 VIAL in 1 CARTON (62756-529-40) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.004MG/ML
Approval Date:	Jan 25, 2013	TE:	AP	RLD:	No

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