Product Details for NDA 050597
AUGMENTIN '125' (AMOXICILLIN; CLAVULANATE POTASSIUM)
125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMOXICILLIN; CLAVULANATE POTASSIUM
Proprietary Name: AUGMENTIN '125'
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050597
Product Number: 001
Approval Date: Jul 22, 1985
Applicant Holder Full Name: US ANTIBIOTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
AUGMENTIN '250' (AMOXICILLIN; CLAVULANATE POTASSIUM)
Proprietary Name: AUGMENTIN '125'
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050597
Product Number: 001
Approval Date: Jul 22, 1985
Applicant Holder Full Name: US ANTIBIOTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMOXICILLIN; CLAVULANATE POTASSIUM
Proprietary Name: AUGMENTIN '250'
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050597
Product Number: 002
Approval Date: Jul 22, 1985
Applicant Holder Full Name: US ANTIBIOTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: AUGMENTIN '250'
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 250MG;EQ 62.5MG 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: N050597
Product Number: 002
Approval Date: Jul 22, 1985
Applicant Holder Full Name: US ANTIBIOTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information