FDA Orange Book
Generic for Bromday
Bromday contains bromfenac. 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 Bromday is bromfenac. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT2.
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Bromday products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 0.09% ACID | Discontinued | None | 5 | AT2 |
NDA 021664, held by BAUSCH AND LOMB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bromfenac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SENTISS AG | 203395 | AT2 (A-rated, therapeutically equivalent) | January 22, 2014 | EQ 0.09% ACID |
| ALEMBIC PHARMACEUTICALS LTD | 210560 | AT2 (A-rated, therapeutically equivalent) | June 21, 2019 | EQ 0.09% ACID |
| GLAND PHARMA LTD | 211029 | AT2 (A-rated, therapeutically equivalent) | March 17, 2020 | EQ 0.09% ACID |
| EUGIA PHARMA SPECIALITIES LTD | 204813 | AT2 (A-rated, therapeutically equivalent) | March 18, 2022 | EQ 0.09% ACID |
| LUPIN LTD | 202903 | AT2 (A-rated, therapeutically equivalent) | August 15, 2023 | EQ 0.09% ACID |
Questions
Is there a generic for Bromday?
Yes. The generic name for Bromday is bromfenac. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT2.
What is the generic name for Bromday?
The active ingredient in Bromday is bromfenac, 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.