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Last Updated: January 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064065

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NDA 064065 describes OTICAIR, which is a drug marketed by Bausch And Lomb and Pharmafair and is included in two NDAs. It is available from four suppliers. Additional details are available on the OTICAIR profile page.

The generic ingredient in OTICAIR is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 064065
Pharmacology for NDA: 064065
Suppliers and Packaging for NDA: 064065
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA Bausch & Lomb Incorporated 24208-635 24208-635-62 1 BOTTLE, DROPPER in 1 CARTON (24208-635-62) > 10 mL in 1 BOTTLE, DROPPER
OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA A-S Medication Solutions 50090-0431 50090-0431-0 1 BOTTLE, DROPPER in 1 CARTON (50090-0431-0) > 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrength1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:Aug 28, 1996TE:ATRLD:No

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