Last Updated: November 8, 2026

Details for New Drug Application (NDA): 215922

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NDA 215922 describes IVERMECTIN, which is a drug marketed by Padagis Israel, Teva Pharms Usa, Zydus Lifesciences, Taro, Ajanta Pharma Ltd, E5 Pharma, Edenbridge Pharms, Epic Pharma Llc, Pharmazone, and Rubicon Research, and is included in twelve NDAs. It is available from twenty-five suppliers. Additional details are available on the IVERMECTIN profile page.

The generic ingredient in IVERMECTIN is ivermectin. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for 215922

Tradename:	IVERMECTIN
Applicant:	Rubicon Research
Ingredient:	ivermectin
Patents:	0

Pharmacology for NDA: 215922

Medical Subject Heading (MeSH) Categories for 215922

Antiparasitic Agents
Insecticides

Suppliers and Packaging for NDA: 215922

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IVERMECTIN	ivermectin	TABLET;ORAL	215922	ANDA	Advagen Pharma Ltd	72888-206	72888-206-09	10 BLISTER PACK in 1 CARTON (72888-206-09) / 10 TABLET in 1 BLISTER PACK (72888-206-08)
IVERMECTIN	ivermectin	TABLET;ORAL	215922	ANDA	Advagen Pharma Ltd	72888-206	72888-206-30	30 TABLET in 1 BOTTLE (72888-206-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Jan 22, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	6MG
Approval Date:	Jan 22, 2025	TE:		RLD:	No

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