FDA Orange Book
Generic for Brovana
Brovana contains arformoterol. 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 Brovana is arformoterol. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
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Brovana products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, inhalation | EQ 0.015MG BASE/2ML | Discontinued | None | 15 | AN |
NDA 021912, held by LUPIN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic arformoterol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ADAPTIS PHARMA PRIVATE LTD | 213762 | AN (A-rated, therapeutically equivalent) | June 22, 2021 | EQ 0.015MG BASE/2ML |
| CIPLA LTD | 207306 | AN (A-rated, therapeutically equivalent) | June 22, 2021 | EQ 0.015MG BASE/2ML |
| LUPIN INC | 213068 | AN (A-rated, therapeutically equivalent) | February 7, 2022 | EQ 0.015MG BASE/2ML |
| THE RITEDOSE CORP | 214736 | AN (A-rated, therapeutically equivalent) | March 2, 2022 | EQ 0.015MG BASE/2ML |
| ALEMBIC PHARMACEUTICALS LTD | 214779 | AN (A-rated, therapeutically equivalent) | May 10, 2022 | EQ 0.015MG BASE/2ML |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 215385 | AN (A-rated, therapeutically equivalent) | May 26, 2022 | EQ 0.015MG BASE/2ML |
| MANKIND PHARMA LTD | 216128 | AN (A-rated, therapeutically equivalent) | November 15, 2022 | EQ 0.015MG BASE/2ML |
| WILSHIRE PHARMACEUTICALS INC | 216815 | AN (A-rated, therapeutically equivalent) | November 25, 2022 | EQ 0.015MG BASE/2ML |
| AIPING PHARMACEUTICAL INC | 214901 | AN (A-rated, therapeutically equivalent) | April 2, 2024 | EQ 0.015MG BASE/2ML |
| NEOCUBES PHARMA LLP | 216303 | AN (A-rated, therapeutically equivalent) | May 17, 2024 | EQ 0.015MG BASE/2ML |
| DR REDDYS LABORATORIES LTD | 215032 | AN (A-rated, therapeutically equivalent) | June 3, 2024 | EQ 0.015MG BASE/2ML |
| LEXENPHARM SUZHOU LTD | 218156 | AN (A-rated, therapeutically equivalent) | November 18, 2024 | EQ 0.015MG BASE/2ML |
| PHARMAZONE | 218380 | AN (A-rated, therapeutically equivalent) | February 3, 2025 | EQ 0.015MG BASE/2ML |
| MICRO LABS LTD | 218555 | AN (A-rated, therapeutically equivalent) | March 7, 2025 | EQ 0.015MG BASE/2ML |
| SABA ILAC SANAYI VE TICARET AS | 218429 | AN (A-rated, therapeutically equivalent) | April 25, 2025 | EQ 0.015MG BASE/2ML |
Questions
Is there a generic for Brovana?
Yes. The generic name for Brovana is arformoterol. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
What is the generic name for Brovana?
The active ingredient in Brovana is arformoterol, 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.