FDA Orange Book
Generic for epiduo forte
epiduo forte contains adapalene and benzoyl peroxide. 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 epiduo forte is adapalene and benzoyl peroxide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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epiduo forte products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 0.3%;2.5% | Marketed (Rx) | AB | 6 | AB |
NDA 207917, held by GALDERMA LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic adapalene and benzoyl peroxide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 209148 | AB (A-rated, therapeutically equivalent) | October 17, 2018 | 0.3%;2.5% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 212464 | AB (A-rated, therapeutically equivalent) | May 31, 2022 | 0.3%;2.5% |
| ZYDUS PHARMACEUTICALS USA INC | 214553 | AB (A-rated, therapeutically equivalent) | June 3, 2022 | 0.3%;2.5% |
| ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 209641 | AB (A-rated, therapeutically equivalent) | June 22, 2022 | 0.3%;2.5% |
| ALEMBIC PHARMACEUTICALS LTD | 214185 | AB (A-rated, therapeutically equivalent) | August 4, 2022 | 0.3%;2.5% |
| AUROBINDO PHARMA LTD | 217384 | AB (A-rated, therapeutically equivalent) | July 22, 2026 | 0.3%;2.5% |
epiduo forte NDC codes
Questions
Is there a generic for epiduo forte?
Yes. The generic name for epiduo forte is adapalene and benzoyl peroxide. 6 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 epiduo forte?
The active ingredient in epiduo forte is adapalene and benzoyl peroxide, 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.