FDA Orange Book
Generic for Avelox
Avelox contains moxifloxacin. 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 Avelox is moxifloxacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Avelox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 400MG BASE | Discontinued | None | 9 | AB |
NDA 021085, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic moxifloxacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 077437 | AB (A-rated, therapeutically equivalent) | February 18, 2014 | EQ 400MG BASE |
| AUROBINDO PHARMA LTD | 202632 | AB (A-rated, therapeutically equivalent) | March 4, 2014 | EQ 400MG BASE |
| DR REDDYS LABORATORIES LTD | 076938 | AB (A-rated, therapeutically equivalent) | March 4, 2014 | EQ 400MG BASE |
| CROSSMEDIKA SA | 205348 | AB (A-rated, therapeutically equivalent) | January 14, 2016 | EQ 400MG BASE |
| CHARTWELL RX SCIENCES LLC | 207285 | AB (A-rated, therapeutically equivalent) | February 13, 2017 | EQ 400MG BASE |
| MSN LABORATORIES PRIVATE LTD | 208682 | AB (A-rated, therapeutically equivalent) | September 22, 2017 | EQ 400MG BASE |
| SUNSHINE LAKE PHARMA CO LTD | 206295 | AB (A-rated, therapeutically equivalent) | September 28, 2018 | EQ 400MG BASE |
| HETERO LABS LTD UNIT V | 204836 | AB (A-rated, therapeutically equivalent) | March 2, 2023 | EQ 400MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 209143 | AB (A-rated, therapeutically equivalent) | March 2, 2026 | EQ 400MG BASE |
Questions
Is there a generic for Avelox?
Yes. The generic name for Avelox is moxifloxacin. 9 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 Avelox?
The active ingredient in Avelox is moxifloxacin, 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.