Product Details for NDA 050605
CEFTIN (CEFUROXIME AXETIL)
EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFUROXIME AXETIL
Proprietary Name: CEFTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050605
Product Number: 001
Approval Date: Dec 28, 1987
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
CEFTIN (CEFUROXIME AXETIL)
Proprietary Name: CEFTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050605
Product Number: 001
Approval Date: Dec 28, 1987
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFUROXIME AXETIL
Proprietary Name: CEFTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050605
Product Number: 002
Approval Date: Dec 28, 1987
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
CEFTIN (CEFUROXIME AXETIL)
Proprietary Name: CEFTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE **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: N050605
Product Number: 002
Approval Date: Dec 28, 1987
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFUROXIME AXETIL
Proprietary Name: CEFTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE **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: N050605
Product Number: 003
Approval Date: Dec 28, 1987
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CEFTIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE **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: N050605
Product Number: 003
Approval Date: Dec 28, 1987
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information