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Generated: June 27, 2017

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 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: 077608

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

Pharmacology for NDA: 077608

Mechanism of ActionCholinesterase Inhibitors

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 0054-0090-21 60 TABLET in 1 BOTTLE (0054-0090-21)
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide
TABLET;ORAL 077608 ANDA West-Ward Pharmaceuticals Corp. 0054-0091 0054-0091-21 60 TABLET in 1 BOTTLE (0054-0091-21)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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