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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 two suppliers. 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. Six suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for NDA: 050742

Merck Sharp Dohme
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 050742

Suppliers and Packaging for NDA: 050742

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
TABLET;ORAL 050742 NDA Department of State Health Services, Pharmacy Branch 55695-019 55695-019-00 2 BLISTER PACK in 1 CARTON (55695-019-00) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

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