Details for New Drug Application (NDA): 208398
✉ Email this page to a colleague
NDA 208398 describes VERMOX, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from one supplier. 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. Two suppliers are listed for this compound. Additional details are available on the mebendazole profile page.
The generic ingredient in VERMOX is mebendazole. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mebendazole profile page.
Summary for 208398
| Tradename: | VERMOX |
| Applicant: | Janssen Pharms |
| Ingredient: | mebendazole |
| Patents: | 0 |
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: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 500MG | ||||
| Approval Date: | Oct 19, 2016 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
