ANDA 214792

BAXTER HLTHCARE CORP

FDA Drug Application

Application #214792

Application Sponsors

ANDA 214792

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.4MG/ML

0

NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214792
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALOXONE HYDROCHLORIDE","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"0.4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-07
        )

)