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Last Updated: May 25, 2020

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Details for New Drug Application (NDA): 210019

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NDA 210019 describes IVERMECTIN, which is a drug marketed by Perrigo Uk Finco, Teva Pharms Usa, and Edenbridge Pharms, and is included in three NDAs. It is available from two 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. Six suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 210019
Applicant:Teva Pharms Usa
Formulation / Manufacturing:see details
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 13, 2019TE:ABRLD:No
Regulatory Exclusivity Expiration:Apr 11, 2020
Regulatory Exclusivity Use:PATENT CHALLENGE

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