FDA Orange Book
Generic for Cutivate
Cutivate contains fluticasone propionate. 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 Cutivate is fluticasone propionate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cutivate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Discontinued | None | 4 | AB |
| lotion, topical | 0.05% | Discontinued | None | 1 | None |
| ointment, topical | 0.005% | Discontinued | None | 2 | AB |
NDA 019958, 021152, 019957, 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 fluticasone propionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ENCUBE ETHICALS PRIVATE LTD | 076633 | AB (A-rated, therapeutically equivalent) | May 14, 2004 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 076451 | AB (A-rated, therapeutically equivalent) | May 14, 2004 | 0.05% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076793 | AB (A-rated, therapeutically equivalent) | May 14, 2004 | 0.05% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076668 | AB (A-rated, therapeutically equivalent) | May 14, 2004 | 0.005% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 077168 | AB (A-rated, therapeutically equivalent) | March 3, 2006 | 0.005% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 077055 | AB (A-rated, therapeutically equivalent) | June 30, 2006 | 0.05% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 091553 | None (No TE code listed) | July 30, 2013 | 0.05% |
Questions
Is there a generic for Cutivate?
Yes. The generic name for Cutivate is fluticasone propionate. 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 Cutivate?
The active ingredient in Cutivate is fluticasone propionate, 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.