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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050628

TOBRASONE (FLUOROMETHOLONE ACETATE; TOBRAMYCIN)
0.1%;0.3%
Marketing Status: Discontinued
Active Ingredient: FLUOROMETHOLONE ACETATE; TOBRAMYCIN
Proprietary Name: TOBRASONE
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.1%;0.3%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050628
Product Number: 001
Approval Date: Jul 21, 1989
Applicant Holder Full Name: HARROW EYE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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