FDA Orange Book

Generic for Tolectin

Tolectin contains tolmetin. 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 Tolectin is tolmetin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Tolectin products the Orange Book lists.

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Tolectin products in the Orange Book

Tolectin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 200MG BASEDiscontinuedNone0None
tablet, oralEQ 600MG BASEDiscontinuedNone1None

NDA 017628, held by ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tolmetin

Approved generic versions of Tolectin
CompanyANDATE codeApprovedStrengths
RISING PHARMA HOLDINGS INC074473None (No TE code listed)August 30, 1994EQ 600MG BASE

Questions

Is there a generic for Tolectin?

Yes. The generic name for Tolectin is tolmetin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Tolectin products the Orange Book lists.

What is the generic name for Tolectin?

The active ingredient in Tolectin is tolmetin, 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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