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Last Updated: March 29, 2025

Details for New Drug Application (NDA): 215210

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NDA 215210 describes IVERMECTIN, which is a drug marketed by Padagis Israel, Teva Pharms Usa, Zydus Lifesciences, Taro, Edenbridge Pharms, Rubicon, and Senores Pharms, and is included in eight NDAs. It is available from eighteen 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-three suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for 215210

Tradename:	IVERMECTIN
Applicant:	Zydus Lifesciences
Ingredient:	ivermectin
Patents:	0

Pharmacology for NDA: 215210

Medical Subject Heading (MeSH) Categories for 215210

Antiparasitic Agents
Insecticides

Suppliers and Packaging for NDA: 215210

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IVERMECTIN	ivermectin	CREAM;TOPICAL	215210	ANDA	Zydus Lifesciences Limited	70771-1728	70771-1728-2	1 TUBE in 1 CARTON (70771-1728-2) / 30 g in 1 TUBE
IVERMECTIN	ivermectin	CREAM;TOPICAL	215210	ANDA	Zydus Lifesciences Limited	70771-1728	70771-1728-3	1 TUBE in 1 CARTON (70771-1728-3) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Aug 2, 2022	TE:	AB	RLD:	No

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