NDA 208901

MAYNE PHARMA INTL

FDA Drug Application

Application #208901

Documents

• Label: 2018-12-12
• Letter: 2018-12-20
• Review: 2019-05-21

Application Sponsors

NDA 208901

MAYNE PHARMA INTL

Marketing Status

• Prescription: 001

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

ORIG

1

Null

40

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
        )

)