Details for New Drug Application (NDA): 219981

NDA 219981 describes DESMOPRESSIN ACETATE, which is a drug marketed by Am Regent, Bedford, Caplin, 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-nine NDAs. It is available from twenty-four 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 219981

Tradename:	DESMOPRESSIN ACETATE
Applicant:	Caplin
Ingredient:	desmopressin acetate
Patents:	0

Pharmacology for NDA: 219981

Physiological Effect

Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Suppliers and Packaging for NDA: 219981

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	219981	ANDA	Caplin Steriles Limited	65145-183	65145-183-10	10 VIAL, SINGLE-DOSE in 1 CARTON (65145-183-10) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-183-01)
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	219981	ANDA	Caplin Steriles Limited	65145-184	65145-184-01	1 VIAL, MULTI-DOSE in 1 CARTON (65145-184-01) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.004MG/ML
Approval Date:	Feb 27, 2026	TE:	AP	RLD:	No

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