Last Updated: November 8, 2026

Details for New Drug Application (NDA): 077605

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NDA 077605 describes GALANTAMINE HYDROBROMIDE, which is a drug marketed by Aurobindo Pharma, Barr, Impax Labs, Pharmobedient, Sun Pharm, Watson Labs, Hikma, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Heritage Pharma, Mylan, Pharmazone, 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for 077605

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

Medical Subject Heading (MeSH) Categories for 077605

Cholinesterase Inhibitors
Nootropic Agents
Parasympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Aug 28, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE
Approval Date:	Aug 28, 2008	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 12MG BASE
Approval Date:	Aug 28, 2008	TE:	AB	RLD:	No

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