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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 210019

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NDA 210019 describes IVERMECTIN, which is a drug marketed by Padagis Israel, Teva Pharms Usa, Zydus, Taro, and Edenbridge Pharms, and is included in six NDAs. It is available from fourteen suppliers. Additional details are available on the IVERMECTIN profile page.

The generic ingredient in IVERMECTIN is ivermectin. There are five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for 210019

Tradename:	IVERMECTIN
Applicant:	Teva Pharms Usa
Ingredient:	ivermectin
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 210019

Medical Subject Heading (MeSH) Categories for 210019

Antiparasitic Agents
Insecticides

Suppliers and Packaging for NDA: 210019

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IVERMECTIN	ivermectin	CREAM;TOPICAL	210019	ANDA	Actavis Pharma, Inc.	0591-4052	0591-4052-89	1 TUBE in 1 CARTON (0591-4052-89) / 45 g in 1 TUBE
IVERMECTIN	ivermectin	CREAM;TOPICAL	210019	ANDA	Bryant Ranch Prepack	63629-8754	63629-8754-1	1 TUBE in 1 CARTON (63629-8754-1) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Sep 13, 2019	TE:	AB	RLD:	No

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