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Active ingredient

Tolterodine

33 finished FDA listings contain Tolterodine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TOLTERODINE, TOLTERODINE TARTRATE
Dosage forms
Capsule, Extended Release, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
15
Strengths listed
1 mg/1 · 2 mg/1 · 4 mg/1
Brand names in FDA listings
Detrol, Tolterodine Tartrate

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 119565

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 020771UPJOHN1998-03-251
ANDA 077006IVAX SUB TEVA PHARMS2015-02-233
ANDA 203016TORRENT2015-08-114
ANDA 203409MACLEODS PHARMS2015-08-312
ANDA 079141TEVA PHARMS USA2016-11-223
ANDA 206419HETERO LABS LTD III2017-12-122
ANDA 204562INVENTIA HLTHCARE2019-08-196
ANDA 204721UNIQUE2020-01-242
ANDA 213397AJANTA PHARMA LTD2020-05-192
ANDA 205399UNICHEM2020-08-052
ANDA 213858UTOPIC PHARMS2021-02-022
ANDA 204397HETERO LABS LTD V2021-08-022
ANDA 216917UNICHEM2024-08-272

Official labeling on DailyMed

Showing the 12 most recent of 17 labels.

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