Documents
Application Sponsors
NDA 213436 | IMPEL NEUROPHARMA INC | |
Marketing Status
Application Products
001 | SPRAY;TOPICAL | 4MG/ML | 0 | DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2021-09-02 | STANDARD |
Submissions Property Types
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
)
)