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Details for New Drug Application (NDA): 017481
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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
Tradename: | VERMOX |
Applicant: | Janssen Pharms |
Ingredient: | mebendazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | 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 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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