APPLICATION
ANDA079141
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-22
LATEST ACTION
2025-06-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
TOLTERODINE TARTRATEPrescription
TOLTERODINE TARTRATE 4MG · CAPSULE, EXTENDED RELEASE · ORAL
TOLTERODINE TARTRATEPrescription
TOLTERODINE TARTRATE 2MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-06-17Labeling · Supplement 14 · standardAP
2020-03-09Labeling · Supplement 1 · standardAP
2016-11-22OriginalAP
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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