FDA Orange Book
Generic for Aclovate
Aclovate contains alclometasone dipropionate. 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 Aclovate is alclometasone dipropionate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Aclovate and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Aclovate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Discontinued | None | 2 | AB |
| ointment, topical | 0.05% | Discontinued | None | 2 | AB |
NDA 018707, 018702, 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 alclometasone dipropionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 076730 | AB (A-rated, therapeutically equivalent) | July 29, 2004 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 076973 | AB (A-rated, therapeutically equivalent) | July 12, 2005 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 076884 | AB (A-rated, therapeutically equivalent) | July 18, 2005 | 0.05% |
| SUN PHARMA CANADA INC | 076587 | AB (A-rated, therapeutically equivalent) | September 15, 2005 | 0.05% |
Questions
Is there a generic for Aclovate?
Yes. The generic name for Aclovate is alclometasone dipropionate. 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 Aclovate?
The active ingredient in Aclovate is alclometasone dipropionate, 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.