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Active ingredient

Galantamine

31 finished FDA listings contain Galantamine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
GALANTAMINE, GALANTAMINE HYDROBROMIDE
Dosage forms
Capsule, Extended Release, Solution, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
9
Strengths listed
12 mg/1 · 16 mg/1 · 24 mg/1 · 4 mg/1 · 4 mg/ml · 8 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4637

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 078185HIKMA2009-01-301
ANDA 077604YABAO PHARM2009-02-069
ANDA 090178SUN PHARM2011-02-029
ANDA 090957AUROBINDO PHARMA LTD2011-03-299
ANDA 204895AUROBINDO PHARMA2016-08-053

Official labeling on DailyMed

Showing the 12 most recent of 17 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.