Details for New Drug Application (NDA): 216904

NDA 216904 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 216904

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

Pharmacology for NDA: 216904

Physiological Effect

Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Suppliers and Packaging for NDA: 216904

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	216904	ANDA	Fresenius Kabi USA, LLC	65219-295	65219-295-10	1 VIAL, MULTI-DOSE in 1 CARTON (65219-295-10) / 10 mL in 1 VIAL, MULTI-DOSE
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	216904	ANDA	Gland Pharma Limited	68083-549	68083-549-01	1 VIAL, MULTI-DOSE in 1 CARTON (68083-549-01) / 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:	Mar 20, 2023	TE:	AP	RLD:	No

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