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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050818

TOBRADEX ST (DEXAMETHASONE; TOBRAMYCIN)
0.05%;0.3%
Marketing Status: Prescription
Active Ingredient: DEXAMETHASONE; TOBRAMYCIN
Proprietary Name: TOBRADEX ST
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.05%;0.3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050818
Product Number: 001
Approval Date: Feb 13, 2009
Applicant Holder Full Name: EYEVANCE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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