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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215352

MYDCOMBI (PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE)
2.5%;1%
Marketing Status: Prescription
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE
Proprietary Name: MYDCOMBI
Dosage Form; Route of Administration: SPRAY, METERED; OPHTHALMIC
Strength: 2.5%;1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215352
Product Number: 001
Approval Date: May 5, 2023
Applicant Holder Full Name: EYENOVIA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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