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General MedicationsOTICGeneric

CORTISPORIN

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Standard Dose
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Discontinued
  • Approval overview CORTISPORIN is listed in Drugs@FDA under application 050479 (NDA).
  • Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Form and strength SOLUTION/DROPS;OTIC - 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor MONARCH PHARMS Submission history Latest submission status date: 2025-08-08 00:00:00.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 050479 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Form and strength SOLUTION/DROPS;OTIC - 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor MONARCH PHARMS Submission history Latest submission status date: 2025-08-08 00:00:00.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.