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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 074830


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NDA 074830 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, 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-seven 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-eight suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.
Summary for 074830
Tradename:DESMOPRESSIN ACETATE
Applicant:Bausch
Ingredient:desmopressin acetate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 074830
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESMOPRESSIN ACETATE desmopressin acetate SPRAY, METERED;NASAL 074830 ANDA Bauch & Lomb Incorporated 24208-342 24208-342-05 1 BOTTLE, PUMP in 1 CARTON (24208-342-05) / 5 mL in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.01MG/SPRAY
Approval Date:Jan 25, 1999TE:ABRLD:No

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