# FLUDROCORTISONE ACETATE
> **ANDA040431** · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS · Approved 2002-03-18
## Drug
- **FDA Application Number:** ANDA040431
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** FLUDROCORTISONE ACETATE
- **Generic name:** FLUDROCORTISONE ACETATE
- **Active ingredients:** FLUDROCORTISONE ACETATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** IMPAX LABS
- **Manufacturer:** Amneal Pharmaceuticals of New York LLC
- **First approval:** 2002-03-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=040431)
---
*AI Analytics · CC0 1.0*