← FDA DRUG APPROVALS

FDA NDA · NDA208398

VERMOX

mebendazole

Sponsor: JANSSEN PHARMS

APPLICATION
NDA208398
TYPE
NDA
ORIGINAL APPROVAL
2016-10-19
LATEST ACTION
2021-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

VERMOX · ReferenceDiscontinued
MEBENDAZOLE 500MG · TABLET, CHEWABLE · ORAL

Approval history

2021-09-20Labeling · Supplement 1 · standard — Label ↗AP
2016-10-19Type 5 - New Formulation or New Manufacturer · Original · priority — Letter ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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