FDA Orange Book
Generic for Cambia
Cambia 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 Cambia is diclofenac. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cambia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 50MG | Marketed (Rx) | AB | 6 | AB |
NDA 022165, held by COSETTE PHARMACEUTICALS INC. 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 |
|---|---|---|---|---|
| PH HEALTH LTD | 202964 | AB (A-rated, therapeutically equivalent) | May 2, 2016 | 50MG |
| ANNORA PHARMA PRIVATE LTD | 215375 | AB (A-rated, therapeutically equivalent) | March 4, 2022 | 50MG |
| ALKEM LABORATORIES LTD | 216635 | AB (A-rated, therapeutically equivalent) | July 20, 2022 | 50MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 218011 | AB (A-rated, therapeutically equivalent) | June 14, 2024 | 50MG |
| TORRENT PHARMACEUTICALS LTD | 215891 | AB (A-rated, therapeutically equivalent) | January 22, 2025 | 50MG |
| UMEDICA LABORATORIES PRIVATE LTD | 217010 | AB (A-rated, therapeutically equivalent) | August 29, 2025 | 50MG |
Cambia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8097651 | June 16, 2026 | Drug substance, Drug product | U-436 | 022165 |
| 7759394 | June 16, 2026 | Drug substance, Drug product | U-436 | 022165 |
| 8927604 | June 16, 2026 | Method of use | U-436 | 022165 |
| 9827197 | June 16, 2026 | Drug product | None | 022165 |
Cambia NDC codes
Questions
Is there a generic for Cambia?
Yes. The generic name for Cambia is diclofenac. 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 Cambia?
The active ingredient in Cambia is diclofenac, per the FDA Orange Book.
When does the Cambia patent expire?
The last patent listed for Cambia in the Orange Book expires June 16, 2026. A listed patent expiry date is not a generic launch date.
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.
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