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Cipla
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078484

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NDA 078484 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 078484
Tradename:GALANTAMINE HYDROBROMIDE
Applicant:Impax Labs
Ingredient:galantamine hydrobromide
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078484

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:May 27, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 16MG BASE
Approval Date:May 27, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 24MG BASE
Approval Date:May 27, 2009TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Deloitte
McKinsey
Argus Health
Accenture
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UBS
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