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CardiovascularTOPICALStandard

KLAYESTA

NYSTATIN

Standard Dose
100,000 UNITS/GM
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview KLAYESTA is listed in Drugs@FDA under application 210532 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NYSTATIN Form and strength POWDER;TOPICAL - 100,000 UNITS/GM Sponsor EPIC PHARMA LLC Submission history Latest submission status date: 2018-04-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview KLAYESTA is listed in Drugs@FDA under application 210532 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NYSTATIN Form and strength POWDER;TOPICAL - 100,000 UNITS/GM Sponsor EPIC PHARMA LLC Submission history Latest submission status date: 2018-04-30 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.