Product Details for NDA 050686
CEDAX (CEFTIBUTEN DIHYDRATE)
EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFTIBUTEN DIHYDRATE
Proprietary Name: CEDAX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050686
Product Number: 001
Approval Date: Dec 20, 1995
Applicant Holder Full Name: SI PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
CEDAX (CEFTIBUTEN DIHYDRATE)
Proprietary Name: CEDAX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050686
Product Number: 001
Approval Date: Dec 20, 1995
Applicant Holder Full Name: SI PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFTIBUTEN DIHYDRATE
Proprietary Name: CEDAX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050686
Product Number: 002
Approval Date: Dec 20, 1995
Applicant Holder Full Name: SI PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CEDAX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050686
Product Number: 002
Approval Date: Dec 20, 1995
Applicant Holder Full Name: SI PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information