← FDA Drug Approvals (Drugs@FDA)
ALBUTEROL SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL IRELAND LTD · Approved 2025-12-01
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown