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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090900

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NDA 090900 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 090900

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

Pharmacology for NDA: 090900

Mechanism of ActionCholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 090900

Suppliers and Packaging for NDA: 090900

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 090900 ANDA Mylan Pharmaceuticals Inc. 0378-8105 0378-8105-93 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8105-93)
GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 090900 ANDA Mylan Pharmaceuticals Inc. 0378-8106 0378-8106-93 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8106-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:Jan 24, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 16MG BASE
Approval Date:Jan 24, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 24MG BASE
Approval Date:Jan 24, 2011TE:ABRLD:No


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