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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210225

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NDA 210225 describes IVERMECTIN, which is a drug marketed by Padagis Israel, Teva Pharms Usa, Zydus Lifesciences, Taro, and Edenbridge Pharms, and is included in six NDAs. It is available from fifteen 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. Twenty suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for 210225

Tradename:	IVERMECTIN
Applicant:	Padagis Israel
Ingredient:	ivermectin
Patents:	0

Pharmacology for NDA: 210225

Medical Subject Heading (MeSH) Categories for 210225

Antiparasitic Agents
Insecticides

Suppliers and Packaging for NDA: 210225

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IVERMECTIN	ivermectin	CREAM;TOPICAL	210225	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-102	45802-102-84	1 TUBE in 1 CARTON (45802-102-84) / 45 g in 1 TUBE
IVERMECTIN	ivermectin	CREAM;TOPICAL	210225	ANDA	Bryant Ranch Prepack	72162-2294	72162-2294-2	1 TUBE in 1 CARTON (72162-2294-2) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Apr 13, 2020	TE:	AB	RLD:	No

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