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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209627

ANNOVERA (ETHINYL ESTRADIOL; SEGESTERONE ACETATE)
0.013MG/24HR;0.15MG/24HR
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Proprietary Name: ANNOVERA
Dosage Form; Route of Administration: RING; VAGINAL
Strength: 0.013MG/24HR;0.15MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209627
Product Number: 001
Approval Date: Aug 10, 2018
Applicant Holder Full Name: MAYNE PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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