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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205947

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM (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: DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205947
Product Number: 001
Approval Date: Jun 13, 2018
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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