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Last Updated: November 13, 2019

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Details for New Drug Application (NDA): 077585

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NDA 077585 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, West-ward Pharms Int, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 077585
Tradename:GALANTAMINE HYDROBROMIDE
Applicant:Heritage Pharma
Ingredient:galantamine hydrobromide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077585

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Sep 15, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Sep 15, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 12MG BASE
Approval Date:Sep 15, 2009TE:RLD:No

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