# ORSERDU
> **NDA217639** · New Drug Application · Sponsor: STEMLINE THERAP · Approved 2023-01-27
## Drug
- **FDA Application Number:** NDA217639
- **Application type:** New Drug Application
- **Brand name:** ORSERDU
- **Generic name:** ELACESTRANT
- **Active ingredients:** ELACESTRANT HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** STEMLINE THERAP
- **Manufacturer:** Stemline Therapeutics, Inc.
- **First approval:** 2023-01-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217639)
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*MORVS · CC0 1.0*