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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200910

XULANE (ETHINYL ESTRADIOL; NORELGESTROMIN)
0.035MG/24HR;0.15MG/24HR
Marketing Status: Prescription
Active Ingredient: ETHINYL ESTRADIOL; NORELGESTROMIN
Proprietary Name: XULANE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.035MG/24HR;0.15MG/24HR
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A200910
Product Number: 001
Approval Date: Apr 16, 2014
Applicant Holder Full Name: MYLAN TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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