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US Army
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 009112

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NDA 009112 describes EURAX, which is a drug marketed by Sun Pharm Inds Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the EURAX profile page.

The generic ingredient in EURAX is crotamiton. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the crotamiton profile page.
Summary for 009112
Tradename:EURAX
Applicant:Sun Pharm Inds Inc
Ingredient:crotamiton
Patents:0
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 009112
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EURAX crotamiton LOTION;TOPICAL 009112 NDA Ranbaxy Laboratories Inc. 10631-092 N 10631-092-16
EURAX crotamiton LOTION;TOPICAL 009112 NDA Ranbaxy Laboratories Inc. 10631-092 N 10631-092-60

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength10%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
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Julphar
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US Department of Justice
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Harvard Business School
Merck

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