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Details for New Drug Application (NDA): 077589

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NDA 077589 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Mylan, Yabao Pharm, Barr, Roxane, Watson Labs, Aurobindo Pharma Ltd, Sun Pharma Global, Apotex Inc, Impax Labs, Actavis Elizabeth, Teva Pharms, Sandoz, Dr Reddys Labs Ltd, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from seventeen suppliers. Additional details are available on the GALANTAMINE HYDROBROMIDE profile page.

The generic ingredient in GALANTAMINE HYDROBROMIDE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for NDA: 077589

galantamine hydrobromide
Therapeutic Class:Antidementia Agents

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jun 22, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Jun 22, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12MG BASE
Approval Date:Jun 22, 2009TE:ABRLD:No

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