APPLICATION
ANDA077605
TYPE
ANDA
ORIGINAL APPROVAL
2008-08-28
LATEST ACTION
2025-02-19
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
2025-02-19Labeling · Supplement 11 · standardAP
2016-04-28Labeling · Supplement 9 · standardAP
2015-11-10Labeling · Supplement 8 · standardAP
2014-08-12Labeling · Supplement 7 · standardAP
2013-01-28Labeling · Supplement 5 · standardAP
2012-10-11Labeling · Supplement 4 · standardAP
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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