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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214594

ETHINYL ESTRADIOL AND NORELGESTROMIN (ETHINYL ESTRADIOL; NORELGESTROMIN)
0.035MG/24HR;0.15MG/24HR
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORELGESTROMIN
Proprietary Name: ETHINYL ESTRADIOL AND NORELGESTROMIN
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.035MG/24HR;0.15MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A214594
Product Number: 001
Approval Date: Sep 14, 2023
Applicant Holder Full Name: ZYDUS NOVELTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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