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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214846

MYFEMBREE (ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX)
1MG;0.5MG;40MG
Marketing Status: Prescription
Active Ingredient: ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Proprietary Name: MYFEMBREE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG;0.5MG;40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214846
Product Number: 001
Approval Date: May 26, 2021
Applicant Holder Full Name: SUMITOMO PHARMA SWITZERLAND GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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