FDA Orange Book
Generic for Temovate
Temovate contains clobetasol propionate. 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 Temovate is clobetasol propionate. 17 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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Temovate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Discontinued | None | 13 | AB1, AB2 |
| gel, topical | 0.05% | Discontinued | None | 3 | AB |
| ointment, topical | 0.05% | Discontinued | None | 10 | AB |
| solution, topical | 0.05% | Discontinued | None | 8 | AT |
NDA 019322, 020337, 019323, 019966, 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 clobetasol propionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 074089 | AB (A-rated, therapeutically equivalent) | February 16, 1994 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 074407 | AB (A-rated, therapeutically equivalent) | February 23, 1996 | 0.05% |
| SUN PHARMA CANADA INC | 074249 | AB1 (A-rated, therapeutically equivalent) | July 8, 1996 | 0.05% |
| SUN PHARMA CANADA INC | 074248 | AB (A-rated, therapeutically equivalent) | July 12, 1996 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 074392 | AB1 (A-rated, therapeutically equivalent) | September 30, 1996 | 0.05% |
| PADAGIS US LLC | 075027 | AB (A-rated, therapeutically equivalent) | October 31, 1997 | 0.05% |
| AUROBINDO PHARMA USA INC | 075057 | AB (A-rated, therapeutically equivalent) | August 12, 1998 | 0.05% |
| SUN PHARMA CANADA INC | 075224 | AT (A-rated, therapeutically equivalent) | November 16, 1998 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 075391 | AT (A-rated, therapeutically equivalent) | February 8, 1999 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 075430 | AB2 (A-rated, therapeutically equivalent) | May 26, 1999 | 0.05% |
| SUN PHARMA CANADA INC | 075279 | AB (A-rated, therapeutically equivalent) | May 28, 1999 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 075368 | AB (A-rated, therapeutically equivalent) | February 15, 2000 | 0.05% |
| SUN PHARMA CANADA INC | 075633 | AB2 (A-rated, therapeutically equivalent) | May 17, 2000 | 0.05% |
| AUROBINDO PHARMA USA INC | 075338 | AB1 (A-rated, therapeutically equivalent) | February 9, 2001 | 0.05% |
| ENCUBE ETHICALS PRIVATE LTD | 076977 | AT (A-rated, therapeutically equivalent) | August 5, 2005 | 0.05% |
| NOVEL LABORATORIES INC | 206075 | AT (A-rated, therapeutically equivalent) | November 23, 2015 | 0.05% |
| BEACH PRODUCTS INC | 209411 | AB2 (A-rated, therapeutically equivalent) | August 21, 2017 | 0.05% |
| MACLEODS PHARMACEUTICALS LTD | 209361 | AT (A-rated, therapeutically equivalent) | October 25, 2017 | 0.05% |
| ZYDUS PHARMACEUTICALS USA INC | 210199 | AB (A-rated, therapeutically equivalent) | October 27, 2017 | 0.05% |
| LUPIN LTD | 210208 | AB1 (A-rated, therapeutically equivalent) | January 30, 2018 | 0.05% |
| XIROMED PHARMA ESPANA SL | 209701 | AB (A-rated, therapeutically equivalent) | April 17, 2018 | 0.05% |
| NOVEL LABORATORIES INC | 208841 | AB (A-rated, therapeutically equivalent) | May 4, 2018 | 0.05% |
| XIROMED PHARMA ESPANA SL | 210034 | AB1 (A-rated, therapeutically equivalent) | June 15, 2018 | 0.05% |
| ZYDUS PHARMACEUTICALS USA INC | 211074 | AB1 (A-rated, therapeutically equivalent) | October 15, 2018 | 0.05% |
| RISING PHARMA HOLDINGS INC | 211401 | AB1 (A-rated, therapeutically equivalent) | January 11, 2019 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 211800 | AB (A-rated, therapeutically equivalent) | March 4, 2019 | 0.05% |
| SAPTALIS PHARMACEUTICALS LLC | 211494 | AT (A-rated, therapeutically equivalent) | October 2, 2019 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 212881 | AT (A-rated, therapeutically equivalent) | October 21, 2019 | 0.05% |
| ENCUBE ETHICALS PRIVATE LTD | 211295 | AB (A-rated, therapeutically equivalent) | November 15, 2019 | 0.05% |
| TORRENT PHARMACEUTICALS LTD | 211836 | AB1 (A-rated, therapeutically equivalent) | December 30, 2019 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 213291 | AB1 (A-rated, therapeutically equivalent) | January 27, 2020 | 0.05% |
| ENCUBE ETHICALS PRIVATE LTD | 212982 | AB1 (A-rated, therapeutically equivalent) | August 28, 2020 | 0.05% |
| QUAGEN PHARMACEUTICALS LLC | 211240 | AT (A-rated, therapeutically equivalent) | February 17, 2022 | 0.05% |
| MACLEODS PHARMACEUTICALS LTD | 215990 | AB (A-rated, therapeutically equivalent) | December 28, 2023 | 0.05% |
Questions
Is there a generic for Temovate?
Yes. The generic name for Temovate is clobetasol propionate. 17 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 Temovate?
The active ingredient in Temovate is clobetasol propionate, 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.