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Last Updated: December 13, 2025

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 eleven 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. Fourteen 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

Pharmacology for NDA: 076369

Medical Subject Heading (MeSH) Categories for 076369

Enzyme Inhibitors
Insecticides

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:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Apr 21, 2003	TE:	AB	RLD:	No

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