FDA Orange Book
Generic for Derma-Smoothe/FS
Derma-Smoothe/FS 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 Derma-Smoothe/FS 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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Derma-Smoothe/FS products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| oil, topical | 0.01% | Marketed (Rx) | AT | 10 | AT |
| oil, topical | 0.01% | Marketed (Rx) | AT | 10 | 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 |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 202847 | AT (A-rated, therapeutically equivalent) | August 9, 2013 | 0.01%, 0.01% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 202848 | AT (A-rated, therapeutically equivalent) | August 9, 2013 | 0.01%, 0.01% |
| RISING PHARMA HOLDINGS INC | 090982 | AT (A-rated, therapeutically equivalent) | April 25, 2016 | 0.01%, 0.01% |
| RISING PHARMA HOLDINGS INC | 203377 | AT (A-rated, therapeutically equivalent) | April 25, 2016 | 0.01%, 0.01% |
| SUN PHARMA CANADA INC | 202368 | AT (A-rated, therapeutically equivalent) | May 19, 2016 | 0.01%, 0.01% |
| SUN PHARMA CANADA INC | 209336 | AT (A-rated, therapeutically equivalent) | May 19, 2016 | 0.01%, 0.01% |
| QUAGEN PHARMACEUTICALS LLC | 212760 | AT (A-rated, therapeutically equivalent) | April 2, 2021 | 0.01%, 0.01% |
| QUAGEN PHARMACEUTICALS LLC | 212761 | AT (A-rated, therapeutically equivalent) | April 2, 2021 | 0.01%, 0.01% |
| NOVEL LABORATORIES INC | 207345 | AT (A-rated, therapeutically equivalent) | July 31, 2023 | 0.01%, 0.01% |
| NOVEL LABORATORIES INC | 207347 | AT (A-rated, therapeutically equivalent) | August 7, 2023 | 0.01%, 0.01% |
Derma-Smoothe/FS NDC codes
Questions
Is there a generic for Derma-Smoothe/FS?
Yes. The generic name for Derma-Smoothe/FS 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 Derma-Smoothe/FS?
The active ingredient in Derma-Smoothe/FS 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.
More on Derma-Smoothe/FS and Fluocinolone Acetonide
- What is Fluocinolone Acetonide used for?FDA label uses
- Is Fluocinolone Acetonide a controlled substance?Federal schedule
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- Generic for IluvienFDA Orange Book
- Generic for DermoticFDA Orange Book
- Corticosteroids listFDA drug class
- NDC 68791-101Derma-Smoothe/FS NDC record
- NDC 68791-102Derma-Smoothe/FS NDC record