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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218718

FEMLYV (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE)
0.02MG;1MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Proprietary Name: FEMLYV
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 0.02MG;1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218718
Product Number: 001
Approval Date: Jul 22, 2024
Applicant Holder Full Name: MILLICENT PUERTO RICO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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