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Generated: February 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017481

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NDA 017481 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 017481
Applicant:Janssen Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 017481
Medical Subject Heading (MeSH) Categories for 017481
Suppliers and Packaging for NDA: 017481
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VERMOX mebendazole TABLET, CHEWABLE;ORAL 017481 NDA Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Division 50580-070 50580-070-12 1 BLISTER PACK in 1 CARTON (50580-070-12) > 12 TABLET, CHEWABLE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 017481

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms VERMOX mebendazole TABLET, CHEWABLE;ORAL 017481-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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Argus Health

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