APPLICATION
ANDA078185
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-30
LATEST ACTION
2023-11-02
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GALANTAMINE HYDROBROMIDEPrescription
GALANTAMINE HYDROBROMIDE 4MG/ML · SOLUTION · ORAL
Approval history
2023-11-02Manufacturing (CMC) · Supplement 8 · unknownAP
2018-07-17Labeling · Supplement 6 · standardAP
2018-07-17Labeling · Supplement 5 · standardAP
2015-11-17Labeling · Supplement 4 · standardAP
2015-11-17Labeling · Supplement 2 · standardAP
2015-11-17Labeling · Supplement 1 · 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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