Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201688

Marketing Status: Prescription
Active Ingredient: TOBRAMYCIN
Proprietary Name: TOBI PODHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 28MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201688
Product Number: 001
Approval Date: Mar 22, 2013
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
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