Last Updated: November 5, 2026

Details for New Drug Application (NDA): 217735


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NDA 217735 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Amneal, Bausch And Lomb Inc, Orbicular Pharm Tech, Sandoz, Saptalis Pharms, and Sciegen Pharms, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 217735
Tradename:NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Applicant:Amneal
Ingredient:hydrocortisone; neomycin sulfate; polymyxin b sulfate
Patents:0
Pharmacology for NDA: 217735
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 217735
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 217735 ANDA Amneal Pharmaceuticals NY LLC 60219-2084 60219-2084-6 1 BOTTLE, PLASTIC in 1 CARTON (60219-2084-6) / 10 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrength1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:Sep 30, 2025TE:ATRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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