Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022574

SAFYRAL (DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM)
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG Marketing Status: Prescription

Active Ingredient: DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Proprietary Name: SAFYRAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022574
Product Number: 001
Approval Date: Dec 16, 2010
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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