Details for New Drug Application (NDA): 213095

NDA 213095 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 213095

Tradename:	DESMOPRESSIN ACETATE
Applicant:	Aurobindo Pharma
Ingredient:	desmopressin acetate
Patents:	0

Pharmacology for NDA: 213095

Physiological Effect

Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Suppliers and Packaging for NDA: 213095

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	213095	ANDA	Aurobindo Pharma Limited	59651-249	59651-249-01	100 TABLET in 1 BOTTLE (59651-249-01)
DESMOPRESSIN ACETATE	desmopressin acetate	TABLET;ORAL	213095	ANDA	Aurobindo Pharma Limited	59651-250	59651-250-01	100 TABLET in 1 BOTTLE (59651-250-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	Mar 21, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.2MG
Approval Date:	Mar 21, 2024	TE:	AB	RLD:	No

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