APPLICATION
ANDA090957
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-29
LATEST ACTION
2023-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 8MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 12MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 4MG BASE · TABLET · ORAL
Approval history
2023-02-02Labeling · Supplement 14 · standardAP
2023-02-02Labeling · Supplement 13 · standardAP
2017-12-14Labeling · Supplement 11 · standardAP
2016-04-19Labeling · Supplement 10 · standardAP
2015-10-26Labeling · Supplement 9 · standardAP
2013-09-29Labeling · Supplement 7 · standardAP
2012-10-12Labeling · Supplement 3 · standardAP
2011-03-29OriginalAP
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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