Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201820

Marketing Status: Prescription
Active Ingredient: TOBRAMYCIN
Proprietary Name: BETHKIS
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: 300MG/4ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AN
Application Number: N201820
Product Number: 001
Approval Date: Oct 12, 2012
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Prescription
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