Details for New Drug Application (NDA): 210218

NDA 210218 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 210218

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

Pharmacology for NDA: 210218

Physiological Effect

Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Suppliers and Packaging for NDA: 210218

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	210218	ANDA	Dr.Reddys' Laboratories Inc	43598-931	43598-931-09	10 AMPULE in 1 BOX (43598-931-09) / 1 mL in 1 AMPULE
DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	210218	ANDA	UBI Pharma Inc.	72843-459	72843-459-10	10 AMPULE in 1 BOX (72843-459-10) / 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.004MG/ML
Approval Date:	Feb 14, 2020	TE:	AP	RLD:	No

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