FDA Orange Book
Generic for Dermatop
Dermatop contains prednicarbate. 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 Dermatop is prednicarbate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Dermatop products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, topical | 0.1% | Discontinued | None | 1 | None |
NDA 019568, held by VALEANT PHARMACEUTICALS NORTH AMERICA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic prednicarbate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 077236 | None (No TE code listed) | March 9, 2007 | 0.1% |
Questions
Is there a generic for Dermatop?
Yes. The generic name for Dermatop is prednicarbate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Dermatop?
The active ingredient in Dermatop is prednicarbate, 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.