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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217603

XDEMVY (LOTILANER)
0.25%
Marketing Status: Prescription
Active Ingredient: LOTILANER
Proprietary Name: XDEMVY
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.25%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217603
Product Number: 001
Approval Date: Jul 24, 2023
Applicant Holder Full Name: TARSUS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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