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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204895

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NDA 204895 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, West-ward Pharms Int, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma, Sandoz, Yabao Pharm, 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. Seventeen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 204895
Tradename:GALANTAMINE HYDROBROMIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:galantamine hydrobromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204895
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 204895
Suppliers and Packaging for NDA: 204895
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 204895 ANDA Aurobindo Pharma Limited 65862-744 65862-744-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-01)
GALANTAMINE HYDROBROMIDE galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 204895 ANDA Aurobindo Pharma Limited 65862-744 65862-744-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:Aug 5, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 16MG BASE
Approval Date:Aug 5, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 24MG BASE
Approval Date:Aug 5, 2016TE:ABRLD:No

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