Drug application
ALBUTEROL SULFATE (ALBUTEROL SULFATE)
Drugs@FDA ANDA 211600 · AMNEAL IRELAND LTD
Key facts
| Drug name | ALBUTEROL SULFATE |
|---|---|
| Active ingredients | ALBUTEROL SULFATE |
| Application type | ANDA |
| Application number | 211600 |
| Company | AMNEAL IRELAND LTD |
| Dosage forms | AEROSOL, METERED, INHALATION |
| Strength | EQ 0.09MG BASE/INH |
| Marketing status | Prescription |
| TE codes | AB2 |
| Reference listed drug | No |
| Latest submission status date | Dec 1, 2025 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.