FDA Orange Book
Generic for Extina
Extina contains ketoconazole. 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 Extina is ketoconazole. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Extina products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, foam, topical | 2% | Discontinued | None | 2 | AB |
NDA 021738, held by RISING PHARMA HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ketoconazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 091550 | AB (A-rated, therapeutically equivalent) | August 25, 2011 | 2% |
| XIROMED PHARMA ESPANA SL | 213601 | AB (A-rated, therapeutically equivalent) | May 21, 2021 | 2% |
Questions
Is there a generic for Extina?
Yes. The generic name for Extina is ketoconazole. 2 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 Extina?
The active ingredient in Extina is ketoconazole, 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.