Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
US Department of Justice

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078185

« Back to Dashboard

NDA 078185 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 078185
Applicant:West-ward Pharms Int
Ingredient:galantamine hydrobromide
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078185
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 078185
Suppliers and Packaging for NDA: 078185
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE galantamine hydrobromide SOLUTION;ORAL 078185 ANDA West-Ward Pharmaceuticals Corp. 0054-0137 N 0054-0137-49

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength4MG/ML
Approval Date:Jan 30, 2009TE:RLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Boehringer Ingelheim
Chinese Patent Office
Argus Health
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.