Documents
Application Sponsors
NDA 212854 | ADAMIS PHARMS CORP | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 5MG/0.5ML | 0 | ZIMHI | NALOXONE HYDROCHLORIDE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2021-10-15 | STANDARD |
Submissions Property Types
CDER Filings
ADAMIS PHARMS CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 212854
[companyName] => ADAMIS PHARMS CORP
[docInserts] => ["",""]
[products] => [{"drugName":"ZIMHI","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"5MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/15\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212854s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212854s000lbl.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-10-15
)
)