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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 065106


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NDA 065106 describes NEOMYCIN AND POLYMYXIN B SULFATE, which is a drug marketed by Watson Labs, Xgen Pharms, Bausch And Lomb, Padagis Us, Sciegen Pharms Inc, Alcon Pharms Ltd, Ipharm, Nordic Pharma, Amring Pharms, and Sandoz, and is included in twenty-one NDAs. It is available from one supplier. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATE profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATE is bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 065106
Pharmacology for NDA: 065106
Suppliers and Packaging for NDA: 065106
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN AND POLYMYXIN B SULFATE neomycin sulfate; polymyxin b sulfate SOLUTION;IRRIGATION 065106 ANDA XGen Pharmaceuticals DJB, Inc. 39822-1201 39822-1201-2 10 AMPULE in 1 CARTON (39822-1201-2) / 1 mL in 1 AMPULE (39822-1201-1)
NEOMYCIN AND POLYMYXIN B SULFATE neomycin sulfate; polymyxin b sulfate SOLUTION;IRRIGATION 065106 ANDA XGen Pharmaceuticals DJB, Inc. 39822-1201 39822-1201-5 50 AMPULE in 1 CARTON (39822-1201-5) / 1 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrengthEQ 40MG BASE/ML;200,000 UNITS/ML
Approval Date:Jan 31, 2006TE:ATRLD:No

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