FDA Orange Book
Generic for Kerydin
Kerydin contains tavaborole. 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 Kerydin is tavaborole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Kerydin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, topical | 5% | Discontinued | None | 4 | AB |
NDA 204427, held by ANACOR PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tavaborole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ENCUBE ETHICALS PRIVATE LTD | 211297 | AB (A-rated, therapeutically equivalent) | October 13, 2020 | 5% |
| ALEMBIC PHARMACEUTICALS LTD | 212188 | AB (A-rated, therapeutically equivalent) | October 21, 2020 | 5% |
| CHARTWELL RX SCIENCES LLC | 211963 | AB (A-rated, therapeutically equivalent) | February 3, 2021 | 5% |
| ZYDUS LIFESCIENCES LTD | 212294 | AB (A-rated, therapeutically equivalent) | April 10, 2023 | 5% |
Questions
Is there a generic for Kerydin?
Yes. The generic name for Kerydin is tavaborole. 4 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 Kerydin?
The active ingredient in Kerydin is tavaborole, 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.