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Baxter
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Generated: October 19, 2017

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 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 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 NDA: 204895

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

Pharmacology for NDA: 204895

Mechanism of ActionCholinesterase Inhibitors

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)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving leading biopharmaceutical companies globally:

Julphar
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