Orange Book product · Brand (NDA)
VERMOX
MEBENDAZOLE
Brand (NDA)NDA 208398DISCN JANSSEN PHARMS
At a glance
Oct 19, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 19, 2016
9 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
MEBENDAZOLE
Strength
500MG
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 208398
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
