APPLICATION
ANDA077590
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-29
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 13 · standardAP
2017-12-14Labeling · Supplement 11 · standardAP
2016-04-28Labeling · Supplement 10 · standardAP
2015-11-10Labeling · Supplement 9 · standardAP
2015-11-10Labeling · Supplement 8 · standardAP
2009-05-29OriginalAP
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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