FDA Orange Book

Generic for Detrol LA

Detrol LA contains tolterodine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Detrol LA is tolterodine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Detrol LA products in the Orange Book

Detrol LA products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, extended release, oral2MGDiscontinuedNone7AB
capsule, extended release, oral4MGDiscontinuedNone7AB

NDA 021228, held by UPJOHN US 2 LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tolterodine

Approved generic versions of Detrol LA
CompanyANDATE codeApprovedStrengths
TORRENT PHARMACEUTICALS LTD203016AB (A-rated, therapeutically equivalent)August 11, 20152MG, 4MG
TEVA PHARMACEUTICALS USA079141AB (A-rated, therapeutically equivalent)November 22, 20162MG, 4MG
HETERO LABS LTD UNIT III206419AB (A-rated, therapeutically equivalent)December 12, 20172MG, 4MG
INVENTIA HEALTHCARE PRIVATE LTD204562AB (A-rated, therapeutically equivalent)August 19, 20192MG, 4MG
AJANTA PHARMA LTD213397AB (A-rated, therapeutically equivalent)May 19, 20202MG, 4MG
UTOPIC PHARMACEUTICALS INC213858AB (A-rated, therapeutically equivalent)February 2, 20212MG, 4MG
UNICHEM LABORATORIES LTD216917AB (A-rated, therapeutically equivalent)August 27, 20242MG, 4MG

Questions

Is there a generic for Detrol LA?

Yes. The generic name for Detrol LA is tolterodine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Detrol LA?

The active ingredient in Detrol LA is tolterodine, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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