# CEDAX
> **NDA050686** · New Drug Application · Sponsor: BURKE THERAP · Approved 1995-12-20
## Drug
- **FDA Application Number:** NDA050686
- **Application type:** New Drug Application
- **Brand name:** CEDAX
- **Generic name:** Ceftibuten Dihydrate
- **Active ingredients:** CEFTIBUTEN DIHYDRATE
- **Dosage form:** FOR SUSPENSION
- **Route:** ORAL
- **Marketing status:** Discontinued
- **Sponsor:** BURKE THERAP
- **First approval:** 1995-12-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050686)
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