APPLICATION
ANDA079028
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-15
LATEST ACTION
2022-06-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 8MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 16MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 24MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2022-06-14Labeling · Supplement 14 · standardAP
2022-06-14Labeling · Supplement 13 · standardAP
2022-06-14Labeling · Supplement 11 · standardAP
2017-12-14Labeling · Supplement 10 · standardAP
2008-12-15OriginalAP
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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