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Generated: September 24, 2018

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Details for New Drug Application (NDA): 060707

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NDA 060707 describes NEOSPORIN G.U. IRRIGANT, which is a drug marketed by Monarch Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the NEOSPORIN G.U. IRRIGANT profile page.

The generic ingredient in NEOSPORIN G.U. IRRIGANT is neomycin sulfate; polymyxin b sulfate. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the neomycin sulfate; polymyxin b sulfate profile page.
Summary for 060707
Pharmacology for NDA: 060707
Suppliers and Packaging for NDA: 060707
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOSPORIN G.U. IRRIGANT neomycin sulfate; polymyxin b sulfate SOLUTION;IRRIGATION 060707 ANDA Pfizer Laboratories Div Pfizer Inc 61570-047 61570-047-10 10 AMPULE in 1 CARTON (61570-047-10) > 1 mL in 1 AMPULE (61570-047-01)
NEOSPORIN G.U. IRRIGANT neomycin sulfate; polymyxin b sulfate SOLUTION;IRRIGATION 060707 ANDA Pfizer Laboratories Div Pfizer Inc 61570-047 61570-047-50 50 AMPULE in 1 CARTON (61570-047-50) > 1 mL in 1 AMPULE (61570-047-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrengthEQ 40MG BASE/ML;200,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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