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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050804

ZYLET (LOTEPREDNOL ETABONATE; TOBRAMYCIN)
0.5%;0.3%
Marketing Status: Prescription
Active Ingredient: LOTEPREDNOL ETABONATE; TOBRAMYCIN
Proprietary Name: ZYLET
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.5%;0.3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050804
Product Number: 001
Approval Date: Dec 14, 2004
Applicant Holder Full Name: BAUSCH AND LOMB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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