Product Details for NDA 050554
PRECEF (CEFORANIDE)
500MG/VIAL
Marketing Status: Discontinued
1GM/VIAL
Marketing Status: Discontinued
2GM/VIAL
Marketing Status: Discontinued
10GM/VIAL
Marketing Status: Discontinued
20GM/VIAL
Marketing Status: Discontinued
500MG/VIAL
Marketing Status: Discontinued
Active Ingredient: CEFORANIDE
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 001
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
PRECEF (CEFORANIDE)
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 500MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 001
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
1GM/VIAL
Marketing Status: Discontinued
Active Ingredient: CEFORANIDE
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 002
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
PRECEF (CEFORANIDE)
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 002
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
2GM/VIAL
Marketing Status: Discontinued
Active Ingredient: CEFORANIDE
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 003
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
PRECEF (CEFORANIDE)
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 003
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
10GM/VIAL
Marketing Status: Discontinued
Active Ingredient: CEFORANIDE
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 004
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
PRECEF (CEFORANIDE)
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 004
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
20GM/VIAL
Marketing Status: Discontinued
Active Ingredient: CEFORANIDE
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 005
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PRECEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20GM/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050554
Product Number: 005
Approval Date: May 24, 1984
Applicant Holder Full Name: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Marketing Status: Discontinued
Patent and Exclusivity Information