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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091345

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NDA 091345 describes DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), which is a drug marketed by Apotex, Sun Pharm, and Zydus Pharms, and is included in three NDAs. It is available from two suppliers. Additional details are available on the DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) profile page.

The generic ingredient in DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION) 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 091345

Tradename:	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
Applicant:	Zydus Pharms
Ingredient:	desmopressin acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.01MG/SPRAY
Approval Date:	Oct 3, 2017	TE:	AB	RLD:	No

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