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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 217803


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NDA 217803 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Amneal, Bausch And Lomb, Sandoz, Saptalis Pharms, and Sciegen Pharms, and is included in eight NDAs. It is available from eleven 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 are sixty-seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 217803
Tradename:NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Applicant:Amneal
Ingredient:hydrocortisone; neomycin sulfate; polymyxin b sulfate
Patents:0
Pharmacology for NDA: 217803
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 217803
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 SOLUTION/DROPS;OTIC 217803 ANDA Amneal Pharmaceuticals NY LLC 60219-2083 60219-2083-1 1 BOTTLE in 1 CARTON (60219-2083-1) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:Oct 29, 2025TE:ATRLD:No

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Preferred Citation:

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