Product Details for NDA 050621
SUPRAX (CEFIXIME)
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFIXIME
Proprietary Name: SUPRAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050621
Product Number: 001
Approval Date: Apr 28, 1989
Applicant Holder Full Name: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing Status: Discontinued
Patent and Exclusivity Information
SUPRAX (CEFIXIME)
Proprietary Name: SUPRAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050621
Product Number: 001
Approval Date: Apr 28, 1989
Applicant Holder Full Name: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing Status: Discontinued
Patent and Exclusivity Information
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFIXIME
Proprietary Name: SUPRAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050621
Product Number: 002
Approval Date: Apr 28, 1989
Applicant Holder Full Name: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SUPRAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050621
Product Number: 002
Approval Date: Apr 28, 1989
Applicant Holder Full Name: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing Status: Discontinued
Patent and Exclusivity Information