Product Details for NDA 050405
KEFLEX (CEPHALEXIN)
EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Active Ingredient: CEPHALEXIN
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: CAPSULE; 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Strength: EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050405
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
KEFLEX (CEPHALEXIN)
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: CAPSULE; 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Strength: EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050405
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
EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: CAPSULE; ORAL
Strength: EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050405
Product Number: 004
Approval Date: May 12, 2006
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
KEFLEX (CEPHALEXIN)
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 333MG 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: N050405
Product Number: 004
Approval Date: May 12, 2006
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
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: CEPHALEXIN
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: CAPSULE; 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: N050405
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: CAPSULE; 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: N050405
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 750MG BASE **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: CAPSULE; ORAL
Strength: EQ 750MG 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: N050405
Product Number: 005
Approval Date: May 12, 2006
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: KEFLEX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 750MG 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: N050405
Product Number: 005
Approval Date: May 12, 2006
Applicant Holder Full Name: PRAGMA PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information