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Details for New Drug Application (NDA): 074830

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NDA 074830 describes DESMOPRESSIN ACETATE, which is a drug marketed by Sun Pharm Inds, Apotex Inc, Hospira, Impax Labs Inc, Bausch And Lomb, Glenmark Pharms Ltd, Mylan Pharms Inc, Actavis Labs Fl Inc, Bedford, Sun Pharm Inds Ltd, Teva Pharms Usa, Ferring, and Sun Pharma Global, and is included in fifteen NDAs. It is available from eighteen suppliers. Additional details are available on the DESMOPRESSIN ACETATE profile page.

The generic ingredient in DESMOPRESSIN ACETATE is desmopressin acetate. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.

Summary for NDA: 074830

Suppliers and Packaging for NDA: 074830

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
desmopressin acetate
SPRAY, METERED;NASAL 074830 ANDA Physicians Total Care, Inc. 54868-5602 54868-5602-0 1 BOTTLE, PUMP in 1 CARTON (54868-5602-0) > 5 mL in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.01MG/SPRAY
Approval Date:Jan 25, 1999TE:ABRLD:Yes

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