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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206334

ORBACTIV (ORITAVANCIN DIPHOSPHATE)
EQ 400MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: ORITAVANCIN DIPHOSPHATE
Proprietary Name: ORBACTIV
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 400MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206334
Product Number: 001
Approval Date: Aug 6, 2014
Applicant Holder Full Name: MELINTA THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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