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General MedicationsOTICStandard

COLY-MYCIN S

COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE

Standard Dose
EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview COLY-MYCIN S is listed in Drugs@FDA under application 050356 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE Form and strength SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML Sponsor PH HEALTH Submission history Latest submission status date: 2019-01-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview COLY-MYCIN S is listed in Drugs@FDA under application 050356 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE Form and strength SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML Sponsor PH HEALTH Submission history Latest submission status date: 2019-01-05 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.