# ORGOVYX
> **NDA214621** · New Drug Application · Sponsor: SUMITOMO PHARMA AM · Approved 2020-12-18
## Drug
- **FDA Application Number:** NDA214621
- **Application type:** New Drug Application
- **Brand name:** ORGOVYX
- **Generic name:** RELUGOLIX
- **Active ingredients:** RELUGOLIX
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SUMITOMO PHARMA AM
- **Manufacturer:** Sumitomo Pharma America, Inc.
- **First approval:** 2020-12-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214621)
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*MORVS · CC0 1.0*