Documents
Application Sponsors
NDA 209388 | EVOKE PHARMA INC | |
Marketing Status
Application Products
001 | SPRAY;NASAL | 15MG | 2 | GIMOTI | METOCLOPRAMIDE |
FDA Submissions
TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination | ORIG | 1 | AP | 2020-06-19 | STANDARD |
Submissions Property Types
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
)
)