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Generated: November 20, 2018

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Details for New Drug Application (NDA): 019855

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NDA 019855 describes ELIMITE, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the ELIMITE profile page.

The generic ingredient in ELIMITE is permethrin. There are five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the permethrin profile page.
Summary for 019855
Tradename:ELIMITE
Applicant:Mylan Pharms Inc
Ingredient:permethrin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019855
Ingredient-typePyrethrins
Medical Subject Heading (MeSH) Categories for 019855
Suppliers and Packaging for NDA: 019855
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELIMITE permethrin CREAM;TOPICAL 019855 NDA Prestium Pharma, Inc. 40076-230 40076-230-60 1 TUBE in 1 CARTON (40076-230-60) > 60 g in 1 TUBE
ELIMITE permethrin CREAM;TOPICAL 019855 NDA AUTHORIZED GENERIC Renaissance Pharma, Inc. 40085-615 40085-615-60 1 TUBE in 1 CARTON (40085-615-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Aug 25, 1989TE:ABRLD:Yes

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