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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211672

XENLETA (LEFAMULIN ACETATE)
EQ 600MG BASE
Marketing Status: Prescription
Active Ingredient: LEFAMULIN ACETATE
Proprietary Name: XENLETA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 600MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211672
Product Number: 001
Approval Date: Aug 19, 2019
Applicant Holder Full Name: NABRIVA THERAPEUTICS IRELAND DAC
Marketing Status:  Prescription
Patent and Exclusivity Information
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