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FDA ANDA · ANDA077587

GALANTAMINE HYDROBROMIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA077587
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-09
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 12MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 4MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 8MG BASE · TABLET · ORAL

Approval history

2023-06-28Labeling · Supplement 3 · standardAP
2017-12-14Labeling · Supplement 2 · standardAP
2009-07-09OriginalAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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