# CASODEX
> **NDA020498** · New Drug Application · Sponsor: ANI PHARMS · Approved 1995-10-04
## Drug
- **FDA Application Number:** NDA020498
- **Application type:** New Drug Application
- **Brand name:** CASODEX
- **Generic name:** BICALUTAMIDE
- **Active ingredients:** BICALUTAMIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ANI PHARMS
- **Manufacturer:** ANI Pharmaceuticals, Inc.
- **First approval:** 1995-10-04
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020498)
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