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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209817

NUZYRA (OMADACYCLINE TOSYLATE)
EQ 100MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: OMADACYCLINE TOSYLATE
Proprietary Name: NUZYRA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 100MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209817
Product Number: 001
Approval Date: Oct 2, 2018
Applicant Holder Full Name: PARATEK PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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