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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078189

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NDA 078189 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 078189

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078189

Mechanism of ActionCholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 078189

Suppliers and Packaging for NDA: 078189

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 078189 ANDA Teva Pharmaceuticals USA, Inc. 0555-1021 0555-1021-01 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0555-1021-01)
GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 078189 ANDA Teva Pharmaceuticals USA, Inc. 0555-1022 0555-1022-01 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0555-1022-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:Sep 15, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 16MG BASE
Approval Date:Sep 15, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 24MG BASE
Approval Date:Sep 15, 2008TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Army
Citi
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US Department of Justice
Merck
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Cipla

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