# ALBUTEROL SULFATE
> **ANDA211600** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL IRELAND LTD · Approved 2025-12-01
## Drug
- **FDA Application Number:** ANDA211600
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ALBUTEROL SULFATE
- **Generic name:** ALBUTEROL SULFATE
- **Active ingredients:** ALBUTEROL SULFATE
- **Dosage form:** AEROSOL, METERED
- **Route:** INHALATION
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL IRELAND LTD
- **Manufacturer:** Amneal Pharmaceuticals NY LLC
- **First approval:** 2025-12-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211600)
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