Drug Index

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

Generic: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Review priority: STANDARD Marketing status: Prescription

Route: OTIC
Class: General Medications
Safety profile: routine
Latest regulatory update: 30 Sept 2025, 12:00 am (UTC)

Structured Monograph

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.