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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205433

KITABIS PAK (TOBRAMYCIN)
300MG/5ML
Marketing Status: Prescription
Active Ingredient: TOBRAMYCIN
Proprietary Name: KITABIS PAK
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: 300MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AN
Application Number: N205433
Product Number: 001
Approval Date: Dec 2, 2014
Applicant Holder Full Name: PULMOFLOW INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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