# ACETYLCYSTEINE
> **ANDA072547** · Abbreviated New Drug Application (Generic) · Sponsor: AM REGENT · Approved 1995-07-28
## Drug
- **FDA Application Number:** ANDA072547
- **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:** AM REGENT
- **Manufacturer:** American Regent, Inc.
- **First approval:** 1995-07-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=072547)
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