Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212667

DAPTOMYCIN (DAPTOMYCIN)
350MG/VIAL Marketing Status: Prescription

Active Ingredient: DAPTOMYCIN
Proprietary Name: DAPTOMYCIN
Dosage Form; Route of Administration: POWDER; IV (INFUSION)
Strength: 350MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A212667
Product Number: 001
Approval Date: Jul 12, 2019
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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