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Last Updated: December 16, 2025

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, Edenbridge Pharms, Epic Pharma Llc, Rubicon Research, and Senores Pharms, and is included in nine 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-two 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
Regulatory Exclusivity Expiration:	Oct 1, 2025
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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