Details for New Drug Application (NDA): 216922

NDA 216922 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 216922

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

Pharmacology for NDA: 216922

Physiological Effect

Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Suppliers and Packaging for NDA: 216922

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	216922	ANDA	Fresenius Kabi USA, LLC	65219-293	65219-293-01	10 VIAL, SINGLE-DOSE in 1 CARTON (65219-293-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-293-00)
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	216922	ANDA	Gland Pharma Limited	68083-550	68083-550-10	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-550-10) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-550-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.004MG/ML
Approval Date:	Nov 16, 2022	TE:	AP	RLD:	No

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