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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076369


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NDA 076369 describes PERMETHRIN, which is a drug marketed by Actavis Labs, Dr Reddys Labs Eu, Encube Ethicals, Padagis Israel, Actavis Mid Atlantic, and Perrigo New York, and is included in six NDAs. It is available from eighteen suppliers. Additional details are available on the PERMETHRIN profile page.

The generic ingredient in PERMETHRIN is permethrin. There are five drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the permethrin profile page.
Summary for 076369
Tradename:PERMETHRIN
Applicant:Padagis Israel
Ingredient:permethrin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076369
Medical Subject Heading (MeSH) Categories for 076369
Suppliers and Packaging for NDA: 076369
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PERMETHRIN permethrin CREAM;TOPICAL 076369 ANDA Northstar Rx LLC 16714-897 16714-897-01 1 TUBE in 1 CONTAINER (16714-897-01) / 60 g in 1 TUBE
PERMETHRIN permethrin CREAM;TOPICAL 076369 ANDA Padagis Israel Pharmaceuticals Ltd 45802-269 45802-269-37 1 TUBE in 1 CARTON (45802-269-37) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Apr 21, 2003TE:ABRLD:No

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