Active ingredient
Arformoterol
15 finished FDA listings contain Arformoterol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ARFORMOTEROL TARTRATE
- Dosage forms
- Solution
- Routes
- Respiratory (Inhalation)
- Manufacturers / labelers
- 15
- Strengths listed
- 15 ug/2ml
- Brand names in FDA listings
- Arformoterol Tartrate Inhalation Solution
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 304962
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 207306 | CIPLA | 2021-06-22 | 1 |
| ANDA 213762 | ADAPTIS | 2021-06-22 | 1 |
| ANDA 213068 | LUPIN | 2022-02-07 | 1 |
| ANDA 214736 | RITEDOSE CORP | 2022-03-02 | 1 |
| ANDA 214779 | ALEMBIC | 2022-05-10 | 1 |
| ANDA 215385 | SUN PHARM | 2022-05-26 | 2 |
| ANDA 216128 | MANKIND PHARMA | 2022-11-15 | 2 |
| ANDA 214901 | AIPING PHARM INC | 2024-04-02 | 1 |
| ANDA 215032 | DR REDDYS | 2024-06-03 | 1 |
| ANDA 218156 | LEXENPHARM | 2024-11-18 | 1 |
| ANDA 218380 | AUCTA | 2025-02-03 | 1 |
| ANDA 218555 | MICRO LABS | 2025-03-07 | 1 |
| ANDA 218429 | SABA ILAC SANAYI | 2025-04-25 | 1 |
Official labeling on DailyMed
- ARFORMOTEROL TARTRATE SOLUTION [AMERICAN HEALTH PACKAGING] · version 4 · 2026-08-24
- ARFORMOTEROL TARTRATE SOLUTION [FOSUN PHARMA USA INC.] · version 3 · 2026-06-15
- ARFORMOTEROL TARTRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 4 · 2026-04-15
- ARFORMOTEROL TARTRATE SOLUTION [LIFESTAR PHARMA LLC] · version 7 · 2026-01-23
- ARFORMOTEROL TARTRATE SOLUTION [NORTHSTAR RXLLC] · version 3 · 2025-12-25
- ARFORMOTEROL TARTRATE SOLUTION [ALEMBIC PHARMACEUTICALS INC.] · version 10 · 2025-12-24
- ARFORMOTEROL TARTRATE INHALATION SOLUTION SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] · version 6 · 2025-12-12
- ARFORMOTEROL TARTRATE SOLUTION [CIPLA USA INC.] · version 6 · 2025-09-01
- ARFORMOTEROL TARTRATE INHALATION SOLUTION [DEVATIS, INC.] · version 1 · 2025-08-04
- ARFORMOTEROL TARTRATE SOLUTION [INGENUS PHARMACEUTICALS, LLC] · version 3 · 2025-06-06
- ARFORMOTEROL TARTRATE (ARFORMOTEROL TARTRATE) SOLUTION [MICRO LABS LIMITED] · version 2 · 2025-05-01
- ARFORMOTEROL TARTRATE SOLUTION [LUPIN PHARMACEUTICALS, INC.] · version 7 · 2025-03-21
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.