NDA 208398

JANSSEN PHARMS

FDA Drug Application

Application #208398

Documents

• Letter: 2016-10-21
• Label: 2016-10-27
• Review: 2016-12-30
• Summary Review: 2016-12-30
• Label: 2021-09-21

Application Sponsors

NDA 208398

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, CHEWABLE;ORAL

500MG

1

VERMOX

MEBENDAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2016-10-19

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208398
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERMOX","activeIngredients":"MEBENDAZOLE","strength":"500MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/20\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208398s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208398s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208398s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208398Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208398Orig1_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208398Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/20\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208398s001lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2021-09-20
        )

)