# LYSODREN
> **NDA016885** · New Drug Application · Sponsor: ESTEVE · Approved 1970-07-08
## Drug
- **FDA Application Number:** NDA016885
- **Application type:** New Drug Application
- **Brand name:** LYSODREN
- **Generic name:** MITOTANE
- **Active ingredients:** MITOTANE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ESTEVE
- **Manufacturer:** ESTEVE PHARMACEUTICALS, S.A.
- **First approval:** 1970-07-08
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=016885)
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