APPLICATION
ANDA077604
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-06
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 12MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 4MG BASE · TABLET · ORAL
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 8MG BASE · TABLET · ORAL
Approval history
2023-06-28Labeling · Supplement 3 · standardAP
2023-06-28Labeling · Supplement 4 · standardAP
2017-12-27Labeling · Supplement 2 · standardAP
2009-02-06OriginalAP
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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