Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207356

EQ 590MG BASE/8.4ML Marketing Status: Prescription

Active Ingredient: AMIKACIN SULFATE
Proprietary Name: ARIKAYCE KIT
Dosage Form; Route of Administration: SUSPENSION, LIPOSOMAL; INHALATION
Strength: EQ 590MG BASE/8.4ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207356
Product Number: 001
Approval Date: Sep 28, 2018
Applicant Holder Full Name: INSMED INC
Marketing Status:  Prescription
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