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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 077589

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NDA 077589 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma, Barr, Impax Labs, Pharmobedient, Sun Pharm, Watson Labs, Hikma, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Heritage Pharma, Mylan, Sandoz, Yabao Pharm, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for 077589

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

Medical Subject Heading (MeSH) Categories for 077589

Cholinesterase Inhibitors
Nootropic Agents
Parasympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Jun 22, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE
Approval Date:	Jun 22, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 12MG BASE
Approval Date:	Jun 22, 2009	TE:	AB	RLD:	No

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