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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 204154

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NDA 204154 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 204154

Tradename:	IVERMECTIN
Applicant:	Edenbridge Pharms
Ingredient:	ivermectin
Patents:	0

Pharmacology for NDA: 204154

Medical Subject Heading (MeSH) Categories for 204154

Antiparasitic Agents
Insecticides

Suppliers and Packaging for NDA: 204154

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IVERMECTIN	ivermectin	TABLET;ORAL	204154	ANDA	Edenbridge Pharmaceuticals LLC.	42799-806	42799-806-01	2 BLISTER PACK in 1 CARTON (42799-806-01) / 10 TABLET in 1 BLISTER PACK
IVERMECTIN	ivermectin	TABLET;ORAL	204154	ANDA	A-S Medication Solutions	50090-5587	50090-5587-0	2 BLISTER PACK in 1 CARTON (50090-5587-0) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Oct 24, 2014	TE:	AB	RLD:	No

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