FDA Orange Book
Generic for Luvox CR
Luvox CR contains fluvoxamine. 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 Luvox CR is fluvoxamine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Luvox CR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 100MG | Discontinued | None | 8 | AB |
| capsule, extended release, oral | 150MG | Discontinued | None | 8 | AB |
NDA 022033, held by JAZZ PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluvoxamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 091476 | AB (A-rated, therapeutically equivalent) | March 13, 2013 | 100MG, 150MG |
| ACTAVIS ELIZABETH LLC | 091482 | AB (A-rated, therapeutically equivalent) | April 23, 2013 | 100MG, 150MG |
| BIONPHARMA INC | 212182 | AB (A-rated, therapeutically equivalent) | September 16, 2020 | 100MG, 150MG |
| AJANTA PHARMA LTD | 219055 | AB (A-rated, therapeutically equivalent) | October 17, 2024 | 100MG, 150MG |
| ANNORA PHARMA PRIVATE LTD | 217024 | AB (A-rated, therapeutically equivalent) | July 30, 2025 | 100MG, 150MG |
| APPCO PHARMA LLC | 220328 | AB (A-rated, therapeutically equivalent) | April 30, 2026 | 100MG, 150MG |
| MICRO LABS LTD | 220768 | AB (A-rated, therapeutically equivalent) | June 23, 2026 | 100MG, 150MG |
| ZYDUS PHARMACEUTICALS USA INC | 220447 | AB (A-rated, therapeutically equivalent) | July 21, 2026 | 100MG, 150MG |
Questions
Is there a generic for Luvox CR?
Yes. The generic name for Luvox CR is fluvoxamine. 8 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 Luvox CR?
The active ingredient in Luvox CR is fluvoxamine, 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.