APPLICATION
ANDA205007
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-17
LATEST ACTION
2024-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
FESOTERODINE FUMARATEPrescription
FESOTERODINE FUMARATE 8MG · TABLET, EXTENDED RELEASE · ORAL
FESOTERODINE FUMARATEPrescription
FESOTERODINE FUMARATE 4MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-11-04Labeling · Supplement 8 · standardAP
2023-02-27Labeling · Supplement 6 · standardAP
2023-02-27Labeling · Supplement 5 · standardAP
2023-02-27Labeling · Supplement 1 · standardAP
2017-02-17UNKNOWN · Original · 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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