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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216160

0.06% (1.25GM/ACTIVATION)
Marketing Status: Prescription
Active Ingredient: ESTRADIOL
Proprietary Name: ESTRADIOL
Dosage Form; Route of Administration: GEL, METERED; TRANSDERMAL
Strength: 0.06% (1.25GM/ACTIVATION)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216160
Product Number: 001
Approval Date: Apr 22, 2024
Applicant Holder Full Name: SOLARIS PHARMA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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