FDA Orange Book
Generic for Temovate E
Temovate E 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 E is clobetasol propionate. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Temovate E 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 |
NDA 020340, 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 |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 074249 | AB1 (A-rated, therapeutically equivalent) | July 8, 1996 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 074392 | AB1 (A-rated, therapeutically equivalent) | September 30, 1996 | 0.05% |
| FOUGERA PHARMACEUTICALS INC | 075430 | AB2 (A-rated, therapeutically equivalent) | May 26, 1999 | 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% |
| BEACH PRODUCTS INC | 209411 | AB2 (A-rated, therapeutically equivalent) | August 21, 2017 | 0.05% |
| LUPIN LTD | 210208 | AB1 (A-rated, therapeutically equivalent) | January 30, 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% |
| 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% |
Questions
Is there a generic for Temovate E?
Yes. The generic name for Temovate E is clobetasol propionate. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Temovate E?
The active ingredient in Temovate E 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.