Product Details for NDA 050460
AMOXIL (AMOXICILLIN)
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMOXICILLIN
Proprietary Name: AMOXIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050460
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
AMOXIL (AMOXICILLIN)
Proprietary Name: AMOXIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050460
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMOXICILLIN
Proprietary Name: AMOXIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050460
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
AMOXIL (AMOXICILLIN)
Proprietary Name: AMOXIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/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: N050460
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMOXICILLIN
Proprietary Name: AMOXIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/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: N050460
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
LAROTID (AMOXICILLIN)
Proprietary Name: AMOXIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/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: N050460
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMOXICILLIN
Proprietary Name: LAROTID
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 50MG/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: N050460
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: LAROTID
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 50MG/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: N050460
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status: Discontinued
Patent and Exclusivity Information