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General MedicationsORALStandard

AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN; CLAVULANATE POTASSIUM

Standard Dose
400MG/5ML;EQ 57MG BASE/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMOXICILLIN AND CLAVULANATE POTASSIUM is listed in Drugs@FDA under application 210416 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMOXICILLIN; CLAVULANATE POTASSIUM Form and strength FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML Sponsor DEVA HOLDING AS Submission history Latest submission status date: 2023-12-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMOXICILLIN AND CLAVULANATE POTASSIUM is listed in Drugs@FDA under application 210416 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMOXICILLIN; CLAVULANATE POTASSIUM Form and strength FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML Sponsor DEVA HOLDING AS Submission history Latest submission status date: 2023-12-11 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.