Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210933

EYSUVIS (LOTEPREDNOL ETABONATE)
0.25%
Marketing Status: Prescription
Active Ingredient: LOTEPREDNOL ETABONATE
Proprietary Name: EYSUVIS
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.25%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210933
Product Number: 001
Approval Date: Oct 26, 2020
Applicant Holder Full Name: KALA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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