# MYFEMBREE
> **NDA214846** · New Drug Application · Sponsor: SUMITOMO PHARMA AM · Approved 2021-05-26
## Drug
- **FDA Application Number:** NDA214846
- **Application type:** New Drug Application
- **Brand name:** MYFEMBREE
- **Generic name:** RELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATE
- **Active ingredients:** ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SUMITOMO PHARMA AM
- **Manufacturer:** Sumitomo Pharma America, Inc
- **First approval:** 2021-05-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214846)
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