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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 077590

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NDA 077590 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma, Barr, Impax Labs, Norvium Bioscience, Sun Pharm, Watson Labs, Hikma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, 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. Twelve suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for 077590

Tradename:	GALANTAMINE HYDROBROMIDE
Applicant:	Mylan
Ingredient:	galantamine hydrobromide
Patents:	0

Medical Subject Heading (MeSH) Categories for 077590

Cholinesterase Inhibitors
Nootropic Agents
Parasympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	May 29, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE
Approval Date:	May 29, 2009	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 12MG BASE
Approval Date:	May 29, 2009	TE:		RLD:	No

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