IMPEL NEUROPHARMA INC FDA Approval NDA 213436

NDA 213436

IMPEL NEUROPHARMA INC

FDA Drug Application

Application #213436

Documents

Letter2021-09-07
Label2021-09-10
Medication Guide2021-09-10

Application Sponsors

NDA 213436IMPEL NEUROPHARMA INC

Marketing Status

Prescription001

Application Products

001SPRAY;TOPICAL4MG/ML0DIHYDROERGOTAMINE MESYLATEDIHYDROERGOTAMINE MESYLATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-09-02STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

IMPEL NEUROPHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213436
            [companyName] => IMPEL NEUROPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIHYDROERGOTAMINE MESYLATE","activeIngredients":"DIHYDROERGOTAMINE MESYLATE","strength":"4MG\/ML","dosageForm":"SPRAY;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213436Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-02
        )

)

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