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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022532

BEYAZ (DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM)
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Marketing Status: Prescription
Active Ingredient: DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Proprietary Name: BEYAZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022532
Product Number: 001
Approval Date: Sep 24, 2010
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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