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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212298

LEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL; LEVONORGESTREL)
0.02MG;0.1MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; LEVONORGESTREL
Proprietary Name: LEVONORGESTREL AND ETHINYL ESTRADIOL
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.02MG;0.1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A212298
Product Number: 001
Approval Date: Feb 13, 2023
Applicant Holder Full Name: HETERO LABS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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