Product Details for NDA 050588
CEFOTAN (CEFOTETAN DISODIUM)
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 10GM BASE/VIAL
Marketing Status: Discontinued
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFOTETAN DISODIUM
Proprietary Name: CEFOTAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050588
Product Number: 001
Approval Date: Dec 27, 1985
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CEFOTAN (CEFOTETAN DISODIUM)
Proprietary Name: CEFOTAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050588
Product Number: 001
Approval Date: Dec 27, 1985
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFOTETAN DISODIUM
Proprietary Name: CEFOTAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050588
Product Number: 002
Approval Date: Dec 27, 1985
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CEFOTAN (CEFOTETAN DISODIUM)
Proprietary Name: CEFOTAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM 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: N050588
Product Number: 002
Approval Date: Dec 27, 1985
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 10GM BASE/VIAL
Marketing Status: Discontinued
Active Ingredient: CEFOTETAN DISODIUM
Proprietary Name: CEFOTAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050588
Product Number: 003
Approval Date: Apr 25, 1988
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CEFOTAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N050588
Product Number: 003
Approval Date: Apr 25, 1988
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status: Discontinued
Patent and Exclusivity Information