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Generated: November 18, 2018

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Details for New Drug Application (NDA): 006927

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NDA 006927 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 six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the crotamiton profile page.
Summary for 006927
Tradename:EURAX
Applicant:Sun Pharm Inds Inc
Ingredient:crotamiton
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 006927
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EURAX crotamiton CREAM;TOPICAL 006927 NDA Ranbaxy Laboratories Inc. 10631-091 10631-091-60 1 TUBE in 1 CARTON (10631-091-60) > 60 g in 1 TUBE

Profile for product number 001

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

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