APPLICATION
ANDA204895
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-05
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 24MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 8MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE EQ 16MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2023-01-17Labeling · Supplement 8 · standardAP
2022-03-17Labeling · Supplement 6 · standardAP
2022-03-17Labeling · Supplement 7 · standardAP
2022-03-17Labeling · Supplement 5 · standardAP
2019-10-24Labeling · Supplement 3 · standardAP
2016-08-05UNKNOWN · OriginalAP
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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