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Active ingredient

Fesoterodine

24 finished FDA listings contain Fesoterodine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FESOTERODINE, FESOTERODINE FUMARATE
Dosage forms
Tablet, Extended Release, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
12
Strengths listed
4 mg/1 · 8 mg/1
Brand names in FDA listings
Toviaz

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 797195

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022030PFIZER2008-10-312
ANDA 204827ALKEM LABS LTD2015-12-102
ANDA 205007AUROBINDO PHARMA2017-02-172
ANDA 204946ZYDUS PHARMS2017-10-034
ANDA 204975DR REDDYS2019-08-134
ANDA 204973ALEMBIC2023-01-044
ANDA 205002AMNEAL PHARMS NY2023-01-042
ANDA 204792HETERO LABS LTD V2024-01-094

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.