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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204057

NORGESTIMATE AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL; NORGESTIMATE)
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORGESTIMATE
Proprietary Name: NORGESTIMATE AND ETHINYL ESTRADIOL
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A204057
Product Number: 001
Approval Date: Feb 23, 2016
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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