Product Details for NDA 215441
BORTEZOMIB (BORTEZOMIB)
2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BORTEZOMIB
Proprietary Name: BORTEZOMIB
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N215441
Product Number: 001
Approval Date: Jul 26, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
BORTEZOMIB (BORTEZOMIB)
Proprietary Name: BORTEZOMIB
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N215441
Product Number: 001
Approval Date: Jul 26, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BORTEZOMIB
Proprietary Name: BORTEZOMIB
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N215441
Product Number: 002
Approval Date: Jul 26, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: BORTEZOMIB
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N215441
Product Number: 002
Approval Date: Jul 26, 2022
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Discontinued
Patent and Exclusivity Information