Last Updated: May 10, 2026

Details for New Drug Application (NDA): 218509

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NDA 218509 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, Rubicon Research, and Senores Pharms, and is included in twelve NDAs. It is available from twenty 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-four suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for 218509

Tradename:	IVERMECTIN
Applicant:	Ajanta Pharma Ltd
Ingredient:	ivermectin
Patents:	0

Pharmacology for NDA: 218509

Medical Subject Heading (MeSH) Categories for 218509

Antiparasitic Agents
Insecticides

Suppliers and Packaging for NDA: 218509

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IVERMECTIN	ivermectin	TABLET;ORAL	218509	ANDA	Ajanta Pharma USA Inc.	27241-293	27241-293-73	2 BLISTER PACK in 1 CARTON (27241-293-73) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Apr 7, 2026	TE:	AB	RLD:	No

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