FDA Orange Book
Generic for Clinoril
Clinoril contains sulindac. 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 Clinoril is sulindac. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Clinoril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Discontinued | None | 3 | AB |
| tablet, oral | 200MG | Discontinued | None | 3 | AB |
NDA 017911, held by MERCK RESEARCH LABORATORIES DIV MERCK CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sulindac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 071891 | AB (A-rated, therapeutically equivalent) | April 3, 1990 | 150MG |
| WATSON LABORATORIES INC | 071795 | AB (A-rated, therapeutically equivalent) | April 3, 1990 | 200MG |
| EPIC PHARMA LLC | 072711 | AB (A-rated, therapeutically equivalent) | March 25, 1991 | 150MG, 200MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 072050 | AB (A-rated, therapeutically equivalent) | April 17, 1991 | 150MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 072051 | AB (A-rated, therapeutically equivalent) | April 17, 1991 | 200MG |
Questions
Is there a generic for Clinoril?
Yes. The generic name for Clinoril is sulindac. 3 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 Clinoril?
The active ingredient in Clinoril is sulindac, 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.