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Serving 500+ biopharmaceutical companies globally:

Colorcon
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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077781

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NDA 077781 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Mylan, Yabao Pharm, Barr, West-ward Pharms Int, Watson Labs, Aurobindo Pharma Ltd, Sun Pharma Global, Apotex Inc, Impax Labs, Actavis Elizabeth, Teva Pharms, Sandoz, Dr Reddys Labs Ltd, 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. Twenty suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for NDA: 077781

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077781

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 077781

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL 077781 ANDA Apotex Corp. 60505-2542 60505-2542-0 10 BLISTER PACK in 1 CARTON (60505-2542-0) > 10 TABLET, FILM COATED in 1 BLISTER PACK
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL 077781 ANDA Apotex Corp. 60505-2542 60505-2542-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-2542-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Sep 27, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Sep 27, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12MG BASE
Approval Date:Sep 27, 2011TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
QuintilesIMS
Chubb
Daiichi Sankyo
Chinese Patent Office
Colorcon
Federal Trade Commission
Merck
Julphar
Fuji

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.

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