FDA Orange Book
Generic for Solaraze
Solaraze contains diclofenac. 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 Solaraze is diclofenac. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Solaraze products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 3% | Discontinued | None | 5 | AB |
NDA 021005, 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 diclofenac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS MID ATLANTIC LLC | 206493 | AB (A-rated, therapeutically equivalent) | December 2, 2015 | 3% |
| SUN PHARMA CANADA INC | 206298 | AB (A-rated, therapeutically equivalent) | April 28, 2016 | 3% |
| GLENMARK PHARMACEUTICALS LTD | 208301 | AB (A-rated, therapeutically equivalent) | September 13, 2016 | 3% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 210893 | AB (A-rated, therapeutically equivalent) | July 27, 2018 | 3% |
| ALEMBIC PHARMACEUTICALS LTD | 212351 | AB (A-rated, therapeutically equivalent) | July 27, 2022 | 3% |
Questions
Is there a generic for Solaraze?
Yes. The generic name for Solaraze is diclofenac. 5 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 Solaraze?
The active ingredient in Solaraze is diclofenac, 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.