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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217415

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DAPTOMYCIN (DAPTOMYCIN)
350MG/VIAL
Marketing Status: Prescription
Active Ingredient: DAPTOMYCIN
Proprietary Name: DAPTOMYCIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 350MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217415
Product Number: 001
Approval Date: Jan 30, 2023
Applicant Holder Full Name: XELLIA PHARMACEUTICALS APS
Marketing Status:  Prescription
Patent and Exclusivity Information
DAPTOMYCIN (DAPTOMYCIN)
500MG/VIAL
Marketing Status: Prescription
Active Ingredient: DAPTOMYCIN
Proprietary Name: DAPTOMYCIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 500MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217415
Product Number: 002
Approval Date: Jan 30, 2023
Applicant Holder Full Name: XELLIA PHARMACEUTICALS APS
Marketing Status:  Prescription
Patent and Exclusivity Information
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