Product Details for NDA 050406
KEFLEX (CEPHALEXIN)
EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*
Marketing Status: Discontinued
EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*
Marketing Status: Discontinued
EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*
Marketing Status: Discontinued
Active Ingredient: CEPHALEXIN
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*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: N050406
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
KEFLEX (CEPHALEXIN)
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*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: N050406
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEPHALEXIN
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050406
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
KEFLEX (CEPHALEXIN)
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 125MG 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: N050406
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*
Marketing Status: Discontinued
Active Ingredient: CEPHALEXIN
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 250MG 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: N050406
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 250MG 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: N050406
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information