Product Details for NDA 050564
AUGMENTIN '250' (AMOXICILLIN; CLAVULANATE POTASSIUM)
250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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; ORAL
Strength: 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050564
Product Number: 001
Approval Date: Aug 6, 1984
Applicant Holder Full Name: US ANTIBIOTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
AUGMENTIN '500' (AMOXICILLIN; CLAVULANATE POTASSIUM)
Proprietary Name: AUGMENTIN '250'
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050564
Product Number: 001
Approval Date: Aug 6, 1984
Applicant Holder Full Name: US ANTIBIOTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 '500'
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050564
Product Number: 002
Approval Date: Aug 6, 1984
Applicant Holder Full Name: US ANTIBIOTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: AUGMENTIN '500'
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 125MG 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: N050564
Product Number: 002
Approval Date: Aug 6, 1984
Applicant Holder Full Name: US ANTIBIOTICS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information