Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET, CHEWABLE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | VERMOX | MEBENDAZOLE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1974-06-28 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1976-03-18 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1975-10-30 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1975-10-30 | PRIORITY |
LABELING; Labeling | SUPPL | 6 | AP | 1976-03-18 | |
LABELING; Labeling | SUPPL | 7 | AP | 1977-03-04 | |
LABELING; Labeling | SUPPL | 8 | AP | 1977-07-29 | |
LABELING; Labeling | SUPPL | 9 | AP | 1977-08-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1978-04-24 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1978-10-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1979-02-15 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1979-09-13 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1979-03-08 | PRIORITY |
LABELING; Labeling | SUPPL | 16 | AP | 1979-03-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1980-04-01 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1980-04-01 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1980-04-03 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1980-12-29 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1981-06-04 | PRIORITY |
LABELING; Labeling | SUPPL | 25 | AP | 1983-07-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1983-03-16 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1983-03-16 | PRIORITY |
LABELING; Labeling | SUPPL | 28 | AP | 1984-05-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1984-08-31 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1984-08-09 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1986-01-26 | PRIORITY |
LABELING; Labeling | SUPPL | 34 | AP | 1989-09-28 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1993-01-28 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1993-01-28 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1993-12-23 | PRIORITY |
LABELING; Labeling | SUPPL | 38 | AP | 1998-02-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1994-06-16 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1995-09-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1998-03-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1998-05-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1998-07-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1998-10-20 | PRIORITY |
LABELING; Labeling | SUPPL | 47 | AP | 2017-06-13 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 32 | Null | 0 |
SUPPL | 35 | Null | 0 |
SUPPL | 36 | Null | 0 |
SUPPL | 37 | Null | 0 |
SUPPL | 40 | Null | 0 |
SUPPL | 41 | Null | 0 |
SUPPL | 42 | Null | 0 |
SUPPL | 43 | Null | 0 |
SUPPL | 44 | Null | 0 |
SUPPL | 45 | Null | 0 |
SUPPL | 47 | Null | 7 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 17481
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"VERMOX","activeIngredients":"MEBENDAZOLE","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"06\/13\/2017","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017481s047lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"VERMOX","submission":"MEBENDAZOLE","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-06-13
)
)