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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202086

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL; NORETHINDRONE)
0.035MG;0.4MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORETHINDRONE
Proprietary Name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.035MG;0.4MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A202086
Product Number: 001
Approval Date: Apr 1, 2015
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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