← FDA Drug Approvals (Drugs@FDA)
MYFEMBREE
NDA · New Drug Application · Sponsor: SUMITOMO PHARMA AM · Approved 2021-05-26
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown