FDA Orange Book
Generic for Impeklo
Impeklo 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 Impeklo is clobetasol propionate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Impeklo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| lotion, topical | 0.05% | Discontinued | None | 4 | AB |
NDA 213691, held by PHARMOBEDIENT CONSULTING 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 |
|---|---|---|---|---|
| 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% |
| LUPIN LTD | 209147 | AB (A-rated, therapeutically equivalent) | September 22, 2017 | 0.05% |
| ZYDUS LIFESCIENCES LTD | 205249 | AB (A-rated, therapeutically equivalent) | September 24, 2019 | 0.05% |
Questions
Is there a generic for Impeklo?
Yes. The generic name for Impeklo is clobetasol propionate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Impeklo?
The active ingredient in Impeklo 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.