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FDA NDA · NDA022030

TOVIAZ

fesoterodine fumarate

Sponsor: PFIZER

APPLICATION
NDA022030
TYPE
NDA
ORIGINAL APPROVAL
2008-10-31
LATEST ACTION
2024-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TOVIAZ · ReferencePrescription
FESOTERODINE FUMARATE 4MG · TABLET, EXTENDED RELEASE · ORAL
TOVIAZ · ReferencePrescription
FESOTERODINE FUMARATE 8MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-02-28Labeling · Supplement 22 · standard — Letter ↗AP
2024-02-28Labeling · Supplement 23 · standard — Letter ↗AP
2021-06-17Efficacy · Supplement 19 · priority — Letter ↗AP
2017-11-12Labeling · Supplement 14 · standard — Label ↗AP
2017-01-26Manufacturing (CMC) · Supplement 12 · standardAP
2014-08-13Manufacturing (CMC) · Supplement 10 · standardAP
2013-01-23Manufacturing (CMC) · Supplement 11 · standardAP
2012-08-01Labeling · Supplement 9 · standard — Letter ↗AP
2011-12-30Labeling · Supplement 8 · standard — Letter ↗AP
2011-11-01Labeling · Supplement 6 · standard — Label ↗AP
2011-02-10Labeling · Supplement 7 · standard — Letter ↗AP
2010-04-02Labeling · Supplement 4 · standard — Label ↗AP
2008-10-31Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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