Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208219

LOTEMAX SM (LOTEPREDNOL ETABONATE)
0.38%
Marketing Status: Prescription
Active Ingredient: LOTEPREDNOL ETABONATE
Proprietary Name: LOTEMAX SM
Dosage Form; Route of Administration: GEL; OPHTHALMIC
Strength: 0.38%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208219
Product Number: 001
Approval Date: Feb 22, 2019
Applicant Holder Full Name: BAUSCH AND LOMB INC
Marketing Status:  Prescription
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