# BICALUTAMIDE
> **ANDA078285** · Abbreviated New Drug Application (Generic) · Sponsor: ROXANE · Approved 2011-03-24
## Drug
- **FDA Application Number:** ANDA078285
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BICALUTAMIDE
- **Generic name:** Bicalutamide
- **Active ingredients:** BICALUTAMIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Discontinued
- **Sponsor:** ROXANE
- **First approval:** 2011-03-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078285)
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