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General MedicationsTOPICALGeneric

CORTISPORIN

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Standard Dose
0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview CORTISPORIN is listed in Drugs@FDA under application 050218 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Form and strength CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor MONARCH PHARMS Submission history Latest submission status date: 2025-08-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview CORTISPORIN is listed in Drugs@FDA under application 050218 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Form and strength CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor MONARCH PHARMS Submission history Latest submission status date: 2025-08-08 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.