Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208611

BAXDELA (DELAFLOXACIN MEGLUMINE)
EQ 300MG BASE/VIAL Marketing Status: Prescription

Active Ingredient: DELAFLOXACIN MEGLUMINE
Proprietary Name: BAXDELA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 300MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208611
Product Number: 001
Approval Date: Jun 19, 2017
Applicant Holder Full Name: MELINTA SUBSIDIARY CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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