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Federal Trade Commission
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077593

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NDA 077593 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharma Global, Watson Labs, West-ward Pharms Int, Actavis Elizabeth, Apotex Inc, Dr Reddys Labs Ltd, Sandoz, Teva Pharms, Yabao Pharm, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from sixteen 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-one suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 077593
Tradename:GALANTAMINE HYDROBROMIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:galantamine hydrobromide
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077593

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Sep 11, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Sep 11, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12MG BASE
Approval Date:Sep 11, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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Express Scripts
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Fish and Richardson
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Johnson and Johnson
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