Documents
Application Sponsors
NDA 214231 | ZEALAND PHARMA AS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 0.6MG/0.6ML | 2 | ZEGALOGUE | DASIGLUCAGON |
002 | SOLUTION;SUBCUTANEOUS | EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) | 1 | ZEGALOGUE (AUTOINJECTOR) | DASIGLUCAGON HYDROCHLORIDE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-03-22 | PRIORITY |
Submissions Property Types
TE Codes
CDER Filings
ZEALAND PHARMA AS
cder:Array
(
[0] => Array
(
[ApplNo] => 214231
[companyName] => ZEALAND PHARMA AS
[docInserts] => ["",""]
[products] => [{"drugName":"ZEGALOGUE","activeIngredients":"DASIGLUCAGON","strength":"0.6MG\/0.6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214231s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214231s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214231Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-03-22
)
)