Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214155

KIMYRSA (ORITAVANCIN DIPHOSPHATE)
EQ 1.2GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: ORITAVANCIN DIPHOSPHATE
Proprietary Name: KIMYRSA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 1.2GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214155
Product Number: 001
Approval Date: Mar 12, 2021
Applicant Holder Full Name: MELINTA THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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