NDA 212045

HIKMA PHARMS

FDA Drug Application

Application #212045

Documents

• Label: 2021-04-30
• Letter: 2021-04-30
• Review: 2021-10-05

Application Sponsors

NDA 212045

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SPRAY;NASAL

8MG

0

KLOXXADO

NALOXONE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-04-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212045
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KLOXXADO","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"8MG","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212045s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/29\/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\\\/212045s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212045Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-04-29
        )

)