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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health

Generated: March 24, 2018

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 five 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-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 050168
Applicant:Monarch Pharms
Ingredient:bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate
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 N 61570-031-50

Profile 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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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson

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