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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078833

DROSPIRENONE AND ETHINYL ESTRADIOL (DROSPIRENONE; ETHINYL ESTRADIOL)
3MG;0.02MG
Marketing Status: Prescription
Active Ingredient: DROSPIRENONE; ETHINYL ESTRADIOL
Proprietary Name: DROSPIRENONE AND ETHINYL ESTRADIOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG;0.02MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078833
Product Number: 001
Approval Date: Nov 28, 2011
Applicant Holder Full Name: WATSON LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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