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Serving leading biopharmaceutical companies globally:

Julphar
Colorcon
Daiichi Sankyo
Healthtrust
US Army
Medtronic
Cipla
Citi
UBS
Farmers Insurance

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050218

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NDA 050218 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 050218
Tradename:CORTISPORIN
Applicant:Monarch Pharms
Ingredient:hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050218
Suppliers and Packaging for NDA: 050218
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORTISPORIN hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate CREAM;TOPICAL 050218 NDA Physicians Total Care, Inc. 54868-1531 E 54868-1531-1
CORTISPORIN hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate CREAM;TOPICAL 050218 NDA Pfizer Laboratories Div Pfizer Inc 61570-032 N 61570-032-75

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:Aug 9, 1985TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Cipla
Daiichi Sankyo
Medtronic
Boehringer Ingelheim
Argus Health
Citi
Dow
Express Scripts

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