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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204703

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE)
0.035MG;1MG
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
Proprietary Name: ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
Dosage Form; Route of Administration: TABLET; ORAL-28
Strength: 0.035MG;1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204703
Product Number: 001
Approval Date: Jul 28, 2016
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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