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Generated: January 17, 2019

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Details for New Drug Application (NDA): 208398

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NDA 208398 describes VERMOX, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the VERMOX profile page.

The generic ingredient in VERMOX is mebendazole. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mebendazole profile page.
Summary for 208398
Applicant:Janssen Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 208398
Medical Subject Heading (MeSH) Categories for 208398
Suppliers and Packaging for NDA: 208398
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VERMOX mebendazole TABLET, CHEWABLE;ORAL 208398 NDA Janssen Pharmaceuticals, Inc. 50458-675 50458-675-20 200 TABLET, CHEWABLE in 1 BOTTLE (50458-675-20)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength500MG
Approval Date:Oct 19, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 19, 2019
Regulatory Exclusivity Use:NEW STRENGTH

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