NDA 212854

ADAMIS PHARMS CORP

FDA Drug Application

Application #212854

Documents

• Label: 2021-10-18
• Letter: 2021-10-19
• Review: 2022-07-18

Application Sponsors

NDA 212854

ADAMIS PHARMS CORP

Marketing Status

• Prescription: 001

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

ORIG

1

Null

7

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
        )

)