EVOKE PHARMA INC FDA Approval NDA 209388

NDA 209388

EVOKE PHARMA INC

FDA Drug Application

Application #209388

Documents

Label2020-06-23
Medication Guide2020-06-23
Letter2020-06-23

Application Sponsors

NDA 209388EVOKE PHARMA INC

Marketing Status

Prescription001

Application Products

001SPRAY;NASAL15MG2GIMOTIMETOCLOPRAMIDE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New CombinationORIG1AP2020-06-19STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

EVOKE PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209388
            [companyName] => EVOKE PHARMA INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/209388s000lbl.pdf#page=17"]
            [products] => [{"drugName":"GIMOTI","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 15MG BASE\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/19\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209388s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209388s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209388Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-19
        )

)

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