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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 050725


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NDA 050725 describes AUGMENTIN '400', which is a drug marketed by Us Antibiotics and is included in two NDAs. It is available from one supplier. Additional details are available on the AUGMENTIN '400' profile page.

The generic ingredient in AUGMENTIN '400' is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 050725
Tradename:AUGMENTIN '400'
Applicant:Us Antibiotics
Ingredient:amoxicillin; clavulanate potassium
Patents:0
Pharmacology for NDA: 050725
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 050725
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUGMENTIN '200' amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050725 NDA Proficient Rx LP 63187-320 63187-320-00 100 mL in 1 BOTTLE (63187-320-00)
AUGMENTIN '400' amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050725 NDA Proficient Rx LP 63187-320 63187-320-00 100 mL in 1 BOTTLE (63187-320-00)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date:May 31, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength400MG/5ML;EQ 57MG BASE/5ML
Approval Date:May 31, 1996TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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