APPLICATION
ANDA077781
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-27
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 10 · standardAP
2021-03-08Labeling · Supplement 8 · standardAP
2021-03-08Labeling · Supplement 9 · standardAP
2017-12-14Labeling · Supplement 5 · standardAP
2016-03-29Labeling · Supplement 4 · standardAP
2016-03-29Labeling · Supplement 2 · standardAP
2016-03-29Labeling · Supplement 3 · standardAP
2012-10-18Labeling · Supplement 1 · standardAP
2011-09-27OriginalAP
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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