Product Details for NDA 050547
CLAFORAN (CEFOTAXIME SODIUM)
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFOTAXIME SODIUM
Proprietary Name: CLAFORAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050547
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STERIMAX INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CLAFORAN (CEFOTAXIME SODIUM)
Proprietary Name: CLAFORAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050547
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STERIMAX INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFOTAXIME SODIUM
Proprietary Name: CLAFORAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050547
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STERIMAX INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CLAFORAN (CEFOTAXIME SODIUM)
Proprietary Name: CLAFORAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL **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: N050547
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STERIMAX INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFOTAXIME SODIUM
Proprietary Name: CLAFORAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL **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: N050547
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STERIMAX INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CLAFORAN (CEFOTAXIME SODIUM)
Proprietary Name: CLAFORAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL **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: N050547
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: STERIMAX INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CEFOTAXIME SODIUM
Proprietary Name: CLAFORAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL **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: N050547
Product Number: 004
Approval Date: Dec 29, 1983
Applicant Holder Full Name: STERIMAX INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CLAFORAN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL **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: N050547
Product Number: 004
Approval Date: Dec 29, 1983
Applicant Holder Full Name: STERIMAX INC
Marketing Status: Discontinued
Patent and Exclusivity Information