FDA Orange Book
Generic for Clobex
Clobex 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 Clobex is clobetasol propionate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Clobex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| lotion, topical | 0.05% | Marketed (Rx) | AB | 4 | AB |
| shampoo, topical | 0.05% | Marketed (Rx) | AB | 4 | AB |
| spray, topical | 0.05% | Marketed (Rx) | AT | 3 | AT |
NDA 021535, 021644, 021835, held by GALDERMA LABORATORIES L P. 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 |
|---|---|---|---|---|
| ACTAVIS MID ATLANTIC LLC | 078223 | AB (A-rated, therapeutically equivalent) | December 4, 2008 | 0.05% |
| SUN PHARMA CANADA INC | 200302 | AB (A-rated, therapeutically equivalent) | July 2, 2012 | 0.05% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 090974 | AB (A-rated, therapeutically equivalent) | August 9, 2012 | 0.05% |
| ZYDUS PHARMACEUTICALS USA INC | 206378 | AT (A-rated, therapeutically equivalent) | February 16, 2017 | 0.05% |
| LUPIN LTD | 209147 | AB (A-rated, therapeutically equivalent) | September 22, 2017 | 0.05% |
| SUN PHARMA CANADA INC | 208842 | AT (A-rated, therapeutically equivalent) | March 26, 2018 | 0.05% |
| ZYDUS LIFESCIENCES LTD | 205249 | AB (A-rated, therapeutically equivalent) | September 24, 2019 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 211191 | AT (A-rated, therapeutically equivalent) | October 2, 2019 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 213290 | AB (A-rated, therapeutically equivalent) | May 18, 2020 | 0.05% |
| SUN PHARMA CANADA INC | 214867 | AB (A-rated, therapeutically equivalent) | March 25, 2021 | 0.05% |
| AMNEAL PHARMACEUTICALS LLC | 214895 | AB (A-rated, therapeutically equivalent) | June 14, 2021 | 0.05% |
Clobex NDC codes
Questions
Is there a generic for Clobex?
Yes. The generic name for Clobex is clobetasol propionate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Clobex?
The active ingredient in Clobex 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.