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Last Updated: September 26, 2020

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Details for New Drug Application (NDA): 090957

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NDA 090957 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 090957
Tradename:GALANTAMINE HYDROBROMIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:galantamine hydrobromide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090957
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 090957
Suppliers and Packaging for NDA: 090957
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 090957 ANDA Rising Health, LLC 57237-049 57237-049-60 60 TABLET, FILM COATED in 1 BOTTLE (57237-049-60)
GALANTAMINE HYDROBROMIDE galantamine hydrobromide TABLET;ORAL 090957 ANDA Rising Health, LLC 57237-050 57237-050-60 60 TABLET, FILM COATED in 1 BOTTLE (57237-050-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Mar 29, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 8MG BASE
Approval Date:Mar 29, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12MG BASE
Approval Date:Mar 29, 2011TE:ABRLD:No

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