Product Details for NDA 021572
CUBICIN (DAPTOMYCIN)
250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DAPTOMYCIN
Proprietary Name: CUBICIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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
CUBICIN (DAPTOMYCIN)
Proprietary Name: CUBICIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DAPTOMYCIN
Proprietary Name: CUBICIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021572
Product Number: 002
Approval Date: Sep 12, 2003
Applicant Holder Full Name: CUBIST PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
CUBICIN RF (DAPTOMYCIN)
Proprietary Name: CUBICIN
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021572
Product Number: 002
Approval Date: Sep 12, 2003
Applicant Holder Full Name: CUBIST PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DAPTOMYCIN
Proprietary Name: CUBICIN RF
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021572
Product Number: 003
Approval Date: Jul 6, 2016
Applicant Holder Full Name: CUBIST PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CUBICIN RF
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021572
Product Number: 003
Approval Date: Jul 6, 2016
Applicant Holder Full Name: CUBIST PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information