Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021572

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CUBICIN (DAPTOMYCIN)
500MG/VIAL Marketing Status: Prescription

Active Ingredient: DAPTOMYCIN
Proprietary Name: CUBICIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 500MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021572
Product Number: 002
Approval Date: Sep 12, 2003
Applicant Holder Full Name: CUBIST PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CUBICIN RF (DAPTOMYCIN)
500MG/VIAL Marketing Status: Prescription

Active Ingredient: DAPTOMYCIN
Proprietary Name: CUBICIN RF
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 500MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021572
Product Number: 003
Approval Date: Jul 6, 2016
Applicant Holder Full Name: CUBIST PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CUBICIN (DAPTOMYCIN)
250MG/VIAL Marketing Status: Discontinued

Active Ingredient: DAPTOMYCIN
Proprietary Name: CUBICIN
Dosage Form; Route of Administration: POWDER; IV (INFUSION)
Strength: 250MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021572
Product Number: 001
Approval Date: Sep 12, 2003
Applicant Holder Full Name: CUBIST PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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