NDA 208223

UPSHER SMITH LABS

FDA Drug Application

Application #208223

Documents

• Letter: 2016-02-01
• Label: 2016-02-11
• Label: 2017-03-28
• Letter: 2017-03-28
• Review: 2017-10-26
• Label: 2019-06-11
• Letter: 2019-06-12

Application Sponsors

NDA 208223

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;SUBCUTANEOUS

EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)

1

ZEMBRACE SYMTOUCH

SUMATRIPTAN SUCCINATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2016-01-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-03-20	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2019-06-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	6
SUPPL	5	Null	15

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208223
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZEMBRACE SYMTOUCH","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 3MG BASE\/0.5ML (EQ 3MG BASE\/0.5ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/10\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208223s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208223Orig1s003lbledt.pdf\"}]","notes":""},{"actionDate":"01\/28\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208223Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/28\/2016","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\\\/2016\\\/208223Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208223Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208223Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/10\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208223s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208223Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"03\/20\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208223Orig1s003lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208223Orig1s003ltredt.pdf\"}]","notes":">"}]
            [actionDate] => 2019-06-10
        )

)