FDA Orange Book
Generic for Lidex
Lidex contains fluocinonide. 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 Lidex is fluocinonide. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2, AT.
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Lidex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Discontinued | None | 10 | AB1, AB2 |
| ointment, topical | 0.05% | Discontinued | None | 5 | AB |
| solution, topical | 0.05% | Discontinued | None | 9 | AT |
NDA 016908, 016909, 018849, held by ALVOGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluocinonide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 071500 | AB1 (A-rated, therapeutically equivalent) | June 10, 1987 | 0.05% |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 072494 | AB2 (A-rated, therapeutically equivalent) | January 19, 1989 | 0.05% |
| TEVA PHARMACEUTICALS USA INC | 072488 | AB1 (A-rated, therapeutically equivalent) | February 6, 1989 | 0.05% |
| TEVA PHARMACEUTICALS USA INC | 072490 | AB2 (A-rated, therapeutically equivalent) | February 7, 1989 | 0.05% |
| TEVA PHARMACEUTICALS USA INC | 073481 | AB (A-rated, therapeutically equivalent) | December 27, 1991 | 0.05% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 073085 | AB1 (A-rated, therapeutically equivalent) | February 14, 1992 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 073030 | AB1 (A-rated, therapeutically equivalent) | October 17, 1994 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 072934 | AT (A-rated, therapeutically equivalent) | February 27, 1995 | 0.05% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 074204 | AB2 (A-rated, therapeutically equivalent) | June 13, 1995 | 0.05% |
| SUN PHARMA CANADA INC | 074799 | AT (A-rated, therapeutically equivalent) | December 31, 1996 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 074905 | AB (A-rated, therapeutically equivalent) | August 26, 1997 | 0.05% |
| SUN PHARMA CANADA INC | 075008 | AB (A-rated, therapeutically equivalent) | June 30, 1999 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 076586 | AB2 (A-rated, therapeutically equivalent) | June 23, 2004 | 0.05% |
| NOVEL LABORATORIES INC | 206003 | AT (A-rated, therapeutically equivalent) | July 21, 2017 | 0.05% |
| CHARTWELL RX SCIENCES LLC | 207538 | AB (A-rated, therapeutically equivalent) | July 31, 2017 | 0.05% |
| CHARTWELL RX SCIENCES LLC | 209118 | AT (A-rated, therapeutically equivalent) | April 23, 2018 | 0.05% |
| MACLEODS PHARMACEUTICALS LTD | 209283 | AT (A-rated, therapeutically equivalent) | April 23, 2018 | 0.05% |
| ZYDUS PHARMACEUTICALS USA INC | 208948 | AT (A-rated, therapeutically equivalent) | July 17, 2018 | 0.05% |
| AMNEAL PHARMACEUTICALS LLC | 210554 | AB1 (A-rated, therapeutically equivalent) | August 21, 2018 | 0.05% |
| ENCUBE ETHICALS PRIVATE LTD | 211410 | AB1 (A-rated, therapeutically equivalent) | October 16, 2018 | 0.05% |
| ENCUBE ETHICALS PVT LTD | 209699 | AT (A-rated, therapeutically equivalent) | November 29, 2018 | 0.05% |
| SCIEGEN PHARMACEUTICALS INC | 207554 | AT (A-rated, therapeutically equivalent) | March 18, 2019 | 0.05% |
| XIROMED PHARMA ESPANA SL | 212976 | AB (A-rated, therapeutically equivalent) | November 26, 2019 | 0.05% |
| QUAGEN PHARMACEUTICALS LLC | 216389 | AT (A-rated, therapeutically equivalent) | February 26, 2025 | 0.05% |
Questions
Is there a generic for Lidex?
Yes. The generic name for Lidex is fluocinonide. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2, AT.
What is the generic name for Lidex?
The active ingredient in Lidex is fluocinonide, 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.