Details for New Drug Application (NDA): 201831

NDA 201831 describes DESMOPRESSIN ACETATE, which is a drug marketed by Am Regent, Bedford, Dr Reddys, Gland, Hospira, Meitheal, Sagent Pharms Inc, Sun Pharm Inds Ltd, UBI, Sun Pharm Inds, Bausch, Abhai Llc, Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Ferring, Glenmark Pharms Ltd, Heritage Pharma, Impax Labs Inc, Natco Pharma Usa, Novast Labs, Sun Pharm, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from twenty-three 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-five suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.

Summary for 201831

Tradename:	DESMOPRESSIN ACETATE
Applicant:	Glenmark Pharms Ltd
Ingredient:	desmopressin acetate
Patents:	0

Pharmacology for NDA: 201831

Physiological Effect

Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Suppliers and Packaging for NDA: 201831

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	201831	ANDA	Glenmark Pharmaceuticals Inc.,USA	68462-275	68462-275-01	100 TABLET in 1 BOTTLE (68462-275-01)
DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	201831	ANDA	Glenmark Pharmaceuticals Inc.,USA	68462-275	68462-275-10	1000 TABLET in 1 BOTTLE (68462-275-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	May 28, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.2MG
Approval Date:	May 28, 2015	TE:		RLD:	No

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