FDA Orange Book

Generic for Lotrimin

Lotrimin contains clotrimazole. 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 Lotrimin is clotrimazole. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT. Generics match 2 of the 3 Lotrimin products the Orange Book lists.

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Lotrimin products in the Orange Book

Lotrimin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
cream, topical1%DiscontinuedNone3AB
lotion, topical1%DiscontinuedNone0None
solution, topical1%DiscontinuedNone5AT

NDA 017619, 018813, 017613, held by SCHERING PLOUGH HEALTHCARE PRODUCTS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic clotrimazole

Approved generic versions of Lotrimin
CompanyANDATE codeApprovedStrengths
SUN PHARMA CANADA INC072640AB (A-rated, therapeutically equivalent)August 31, 19931%
TEVA PHARMACEUTICALS USA INC073306AT (A-rated, therapeutically equivalent)February 28, 19951%
SUN PHARMA CANADA INC074580AT (A-rated, therapeutically equivalent)July 29, 19961%
FOUGERA PHARMACEUTICALS INC078338AB (A-rated, therapeutically equivalent)September 2, 20081%
GLENMARK PHARMACEUTICALS INC USA090219AB (A-rated, therapeutically equivalent)August 3, 20101%
NOVITIUM PHARMA LLC209815AT (A-rated, therapeutically equivalent)February 14, 20191%
TP ANDA HOLDINGS LLC212281AT (A-rated, therapeutically equivalent)July 25, 20191%
SCIEGEN PHARMACEUTICALS INC216569AT (A-rated, therapeutically equivalent)October 16, 20231%

Questions

Is there a generic for Lotrimin?

Yes. The generic name for Lotrimin is clotrimazole. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT. Generics match 2 of the 3 Lotrimin products the Orange Book lists.

What is the generic name for Lotrimin?

The active ingredient in Lotrimin is clotrimazole, 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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