# ACETADOTE
> **NDA021539** · New Drug Application · Sponsor: CUMBERLAND PHARMS · Approved 2004-01-23
## Drug
- **FDA Application Number:** NDA021539
- **Application type:** New Drug Application
- **Brand name:** ACETADOTE
- **Generic name:** ACETYLCYSTEINE
- **Active ingredients:** ACETYLCYSTEINE
- **Dosage form:** INJECTABLE
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** CUMBERLAND PHARMS
- **Manufacturer:** Cumberland Pharmaceuticals Inc.
- **First approval:** 2004-01-23
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021539)
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