FDA Orange Book
Generic for Voltaren-xr
Voltaren-xr 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 Voltaren-xr is diclofenac. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Voltaren-xr products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 100MG | Discontinued | None | 4 | AB |
NDA 020254, held by NOVARTIS PHARMACEUTICALS CORP. 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 |
|---|---|---|---|---|
| VALEANT PHARMACEUTICALS NORTH AMERICA | 075492 | AB (A-rated, therapeutically equivalent) | February 11, 2000 | 100MG |
| AUROBINDO PHARMA USA INC | 076152 | AB (A-rated, therapeutically equivalent) | December 13, 2001 | 100MG |
| DEXCEL LTD | 076201 | AB (A-rated, therapeutically equivalent) | November 6, 2002 | 100MG |
| INGENUS PHARMACEUTICALS LLC | 216275 | AB (A-rated, therapeutically equivalent) | September 23, 2022 | 100MG |
Questions
Is there a generic for Voltaren-xr?
Yes. The generic name for Voltaren-xr is diclofenac. 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 Voltaren-xr?
The active ingredient in Voltaren-xr 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.