NDA 210884

UPSHER SMITH LABS

FDA Drug Application

Application #210884

Documents

• Label: 2019-01-30
• Letter: 2019-02-13
• Review: 2019-09-13

Application Sponsors

NDA 210884

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

SPRAY;NASAL

10MG/SPRAY

1

TOSYMRA

SUMATRIPTAN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2019-01-25

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210884
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOSYMRA","activeIngredients":"SUMATRIPTAN","strength":"10MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/25\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210884s000lbledt.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210884s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210884Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/210884Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-01-25
        )

)