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1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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- 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor MONARCH PHARMS Submission history Latest submission status date: 2025-08-08 00:00:00.

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- 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor MONARCH PHARMS Submission history Latest submission status date: 2025-08-08 00:00:00.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.