APPLICATION
ANDA203016
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-11
LATEST ACTION
2025-08-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
TOLTERODINE TARTRATEPrescription
TOLTERODINE TARTRATE 2MG · CAPSULE, EXTENDED RELEASE · ORAL
TOLTERODINE TARTRATEPrescription
TOLTERODINE TARTRATE 4MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-08-21Labeling · Supplement 9 · standardAP
2020-03-09Labeling · Supplement 3 · standardAP
2015-08-11UNKNOWN · 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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