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Details for New Drug Application (NDA): 200653

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NDA 200653 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: 200653

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.1MG
Approval Date:Jun 27, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:Jun 27, 2014TE:ABRLD:No

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