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Last Updated: April 4, 2026

Details for New Drug Application (NDA): 078185

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NDA 078185 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, Sandoz, Senores Pharms, 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 078185

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

Pharmacology for NDA: 078185

Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for 078185

Cholinesterase Inhibitors
Nootropic Agents
Parasympathomimetics

Suppliers and Packaging for NDA: 078185

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	SOLUTION;ORAL	078185	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0137	0054-0137-49	100 mL in 1 BOTTLE (0054-0137-49)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	4MG/ML
Approval Date:	Jan 30, 2009	TE:		RLD:	No

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