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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050168

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NDA 050168 describes CORTISPORIN, which is a drug marketed by Monarch Pharms and Casper Pharma Llc and is included in six NDAs. It is available from two suppliers. Additional details are available on the CORTISPORIN profile page.

The generic ingredient in CORTISPORIN is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for 050168

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050168

Suppliers and Packaging for NDA: 050168

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORTISPORIN bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;TOPICAL 050168 NDA Pfizer Laboratories Div Pfizer Inc 61570-031 61570-031-50 1 TUBE, WITH APPLICATOR in 1 CARTON (61570-031-50) > 14.2 g in 1 TUBE, WITH APPLICATOR

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM
Approval Date:May 4, 1984TE:RLD:Yes


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Deloitte
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Dow
Daiichi Sankyo
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Baxter
QuintilesIMS

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