Documents
Application Sponsors
NDA 208901 | MAYNE PHARMA INTL | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 65MG | 1 | TOLSURA | ITRACONAZOLE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2018-12-11 | STANDARD |
Submissions Property Types
CDER Filings
MAYNE PHARMA INTL
cder:Array
(
[0] => Array
(
[ApplNo] => 208901
[companyName] => MAYNE PHARMA INTL
[docInserts] => ["",""]
[products] => [{"drugName":"TOLSURA","activeIngredients":"ITRACONAZOLE","strength":"65MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/11\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208901s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208901s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208901Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208901Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2018-12-11
)
)