# ACETYLCYSTEINE
> **ANDA215620** · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2022-02-23
## Drug
- **FDA Application Number:** ANDA215620
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ACETYLCYSTEINE
- **Generic name:** ACETYLCYSTEINE
- **Active ingredients:** ACETYLCYSTEINE
- **Dosage form:** INJECTABLE
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** REGCON HOLDINGS
- **Manufacturer:** Indoco Remedies Limited
- **First approval:** 2022-02-23
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215620)
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