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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210019


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NDA 210019 describes IVERMECTIN, which is a drug marketed by Padagis Israel, Teva Pharms Usa, Zydus Lifesciences, Taro, and Edenbridge Pharms, and is included in six NDAs. It is available from fifteen 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 suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 210019
Tradename:IVERMECTIN
Applicant:Teva Pharms Usa
Ingredient:ivermectin
Patents:0
Pharmacology for NDA: 210019
Medical Subject Heading (MeSH) Categories for 210019
Suppliers and Packaging for NDA: 210019
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IVERMECTIN ivermectin CREAM;TOPICAL 210019 ANDA Actavis Pharma, Inc. 0591-4052 0591-4052-89 1 TUBE in 1 CARTON (0591-4052-89) / 45 g in 1 TUBE
IVERMECTIN ivermectin CREAM;TOPICAL 210019 ANDA Bryant Ranch Prepack 63629-8754 63629-8754-1 1 TUBE in 1 CARTON (63629-8754-1) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 13, 2019TE:ABRLD:No

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