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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202689

VOLNEA (DESOGESTREL; ETHINYL ESTRADIOL)
0.15MG,N/A;0.02MG,0.01MG
Marketing Status: Prescription
Active Ingredient: DESOGESTREL; ETHINYL ESTRADIOL
Proprietary Name: VOLNEA
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.15MG,N/A;0.02MG,0.01MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202689
Product Number: 001
Approval Date: Sep 9, 2016
Applicant Holder Full Name: XIROMED PHARMA ESPANA SL
Marketing Status:  Prescription
Patent and Exclusivity Information
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