➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
McKinsey
Merck
McKesson
Moodys

Last Updated: December 1, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204895

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 204895 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Impax Labs, Mylan, Sun Pharm, Watson Labs, Hikma, 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 twelve 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. Fourteen 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Colorcon
AstraZeneca
Harvard Business School
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.