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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209776

VABOMERE (MEROPENEM; VABORBACTAM)
1GM/VIAL;1GM/VIAL
Marketing Status: Prescription
Active Ingredient: MEROPENEM; VABORBACTAM
Proprietary Name: VABOMERE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 1GM/VIAL;1GM/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209776
Product Number: 001
Approval Date: Aug 29, 2017
Applicant Holder Full Name: REMPEX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF MELINTA THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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