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Serving hundreds of leading biopharmaceutical companies globally:

Merck
US Army
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Cipla
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US Department of Justice
Citi
Covington

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077608

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NDA 077608 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 077608
Tradename:GALANTAMINE HYDROBROMIDE
Applicant:West-ward Pharms Int
Ingredient:galantamine hydrobromide
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077608
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 077608
Suppliers and Packaging for NDA: 077608
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077608 ANDA West-Ward Pharmaceuticals Corp. 0054-0090 N 0054-0090-21
GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 077608 ANDA West-Ward Pharmaceuticals Corp. 0054-0091 N 0054-0091-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Feb 11, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Feb 11, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12MG BASE
Approval Date:Feb 11, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
Argus Health
Teva
Julphar
Chinese Patent Office
McKinsey
Healthtrust
Baxter

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