BAXTER HLTHCARE CORP FDA Approval ANDA 214785

ANDA 214785

BAXTER HLTHCARE CORP

FDA Drug Application

Application #214785

Application Sponsors

ANDA 214785BAXTER HLTHCARE CORP

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.4MG/ML0NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214785
            [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":"NALOXONE HYDROCHLORIDE","submission":"NALOXONE HYDROCHLORIDE","actionType":"0.4MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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