Product Details for NDA 050443
BLENOXANE (BLEOMYCIN SULFATE)
EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BLEOMYCIN SULFATE
Proprietary Name: BLENOXANE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050443
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
BLENOXANE (BLEOMYCIN SULFATE)
Proprietary Name: BLENOXANE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050443
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BLEOMYCIN SULFATE
Proprietary Name: BLENOXANE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050443
Product Number: 002
Approval Date: Sep 7, 1995
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: BLENOXANE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 30 UNITS BASE/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: N050443
Product Number: 002
Approval Date: Sep 7, 1995
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Marketing Status: Discontinued
Patent and Exclusivity Information