APPLICATION
ANDA090900
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-24
LATEST ACTION
2019-10-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 16MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 24MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
GALANTAMINE HYDROBROMIDEDiscontinued
GALANTAMINE HYDROBROMIDE EQ 8MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2019-10-25Labeling · Supplement 8 · standardAP
2016-04-28Labeling · Supplement 6 · standardAP
2015-11-09Labeling · Supplement 4 · standardAP
2015-11-09Labeling · Supplement 5 · standardAP
2011-01-24OriginalAP
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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