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General MedicationsOTICStandard

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Standard Dose
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is listed in Drugs@FDA under application 217735 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Form and strength SUSPENSION/DROPS;OTIC - 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML Sponsor AMNEAL Submission history Latest submission status date: 2025-09-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is listed in Drugs@FDA under application 217735 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Form and strength SUSPENSION/DROPS;OTIC - 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML Sponsor AMNEAL Submission history Latest submission status date: 2025-09-30 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.