# ACETYLCYSTEINE
> **ANDA219194** · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2025-02-12
## Drug
- **FDA Application Number:** ANDA219194
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ACETYLCYSTEINE
- **Generic name:** ACETYLCYSTEINE
- **Active ingredients:** ACETYLCYSTEINE
- **Dosage form:** SOLUTION
- **Route:** INHALATION, ORAL
- **Marketing status:** Prescription
- **Sponsor:** SOMERSET THERAPS LLC
- **Manufacturer:** Somerset Therapeutics, LLC
- **First approval:** 2025-02-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219194)
---
*AI Analytics · CC0 1.0*