FDA Orange Book
Generic for Dermotic
Dermotic contains fluocinolone acetonide. 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 Dermotic is fluocinolone acetonide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Dermotic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| oil/drops, otic | 0.01% | Marketed (Rx) | AT | 5 | AT |
NDA 019452, held by HILL DERMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluocinolone acetonide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 203378 | AT (A-rated, therapeutically equivalent) | April 25, 2016 | 0.01% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 202849 | AT (A-rated, therapeutically equivalent) | July 17, 2017 | 0.01% |
| ANDA REPOSITORY LLC | 210736 | AT (A-rated, therapeutically equivalent) | April 11, 2018 | 0.01% |
| TP ANDA HOLDINGS LLC | 213264 | AT (A-rated, therapeutically equivalent) | February 5, 2021 | 0.01% |
| QUAGEN PHARMACEUTICALS LLC | 212762 | AT (A-rated, therapeutically equivalent) | April 2, 2021 | 0.01% |
Dermotic NDC codes
Questions
Is there a generic for Dermotic?
Yes. The generic name for Dermotic is fluocinolone acetonide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Dermotic?
The active ingredient in Dermotic is fluocinolone acetonide, 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.