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Last Updated: January 22, 2021

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Details for New Drug Application (NDA): 050742

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NDA 050742 describes STROMECTOL, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. Additional details are available on the STROMECTOL profile page.

The generic ingredient in STROMECTOL is ivermectin. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Summary for 050742
Applicant:Merck Sharp Dohme
Formulation / Manufacturing:see details
Pharmacology for NDA: 050742
Medical Subject Heading (MeSH) Categories for 050742
Suppliers and Packaging for NDA: 050742
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STROMECTOL ivermectin TABLET;ORAL 050742 NDA Merck Sharp & Dohme Corp. 0006-0032 0006-0032-20 2 BLISTER PACK in 1 CARTON (0006-0032-20) > 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength6MG
Approval Date:Nov 22, 1996TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Oct 8, 1998TE:ABRLD:Yes

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