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General MedicationsORALStandard

ATOVAQUONE

ATOVAQUONE

Standard Dose
750MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ATOVAQUONE is listed in Drugs@FDA under application 214272 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ATOVAQUONE Form and strength SUSPENSION;ORAL - 750MG/5ML Sponsor PAI HOLDINGS Submission history Latest submission status date: 2021-10-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview ATOVAQUONE is listed in Drugs@FDA under application 214272 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ATOVAQUONE Form and strength SUSPENSION;ORAL - 750MG/5ML Sponsor PAI HOLDINGS Submission history Latest submission status date: 2021-10-25 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.