APPLICATION
ANDA077608
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-11
LATEST ACTION
2022-03-22
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
2022-03-22Labeling · Supplement 7 · standardAP
2022-03-22Labeling · Supplement 6 · standardAP
2018-07-17Labeling · Supplement 5 · standardAP
2018-07-17Labeling · Supplement 3 · standardAP
2015-11-24Labeling · Supplement 1 · standardAP
2015-11-24Labeling · Supplement 2 · standardAP
2009-02-11OriginalAP
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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