FDA Orange Book
Generic for Oxistat
Oxistat contains oxiconazole nitrate. 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 Oxistat is oxiconazole nitrate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Oxistat products the Orange Book lists.
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Oxistat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 1% BASE | Marketed (Rx) | AB | 1 | AB |
| lotion, topical | EQ 1% BASE | Discontinued | None | 0 | None |
NDA 019828, 020209, held by FOUGERA PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxiconazole nitrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 205076 | AB (A-rated, therapeutically equivalent) | March 7, 2016 | EQ 1% BASE |
Oxistat NDC codes
Questions
Is there a generic for Oxistat?
Yes. The generic name for Oxistat is oxiconazole nitrate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Oxistat products the Orange Book lists.
What is the generic name for Oxistat?
The active ingredient in Oxistat is oxiconazole nitrate, 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.