Treats gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and…. NDA 208398, held by Janssen Pharms. Mebendazole.
As of Nov 14, 2026, NDA 208398 (Vermox), held by Janssen Pharms, was first approved by FDA on Oct 19, 2016, with 1 approved supplement and 0 published complete response letters.
VERMOX CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2016 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vermox500MG · tablet, chewable;oral | Mebendazole | DiscontinuedReference drug |
| Sep 20, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Oct 19, 2016 | Original applicationNew formulation or manufacturer · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
