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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208357

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NDA 208357 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 208357

Tradename:	DESMOPRESSIN ACETATE
Applicant:	Novast Labs
Ingredient:	desmopressin acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	Jun 6, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.2MG
Approval Date:	Jun 6, 2019	TE:	AB	RLD:	No

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