HIKMA FDA Approval ANDA 213630

ANDA 213630

HIKMA

FDA Drug Application

Application #213630

Application Sponsors

ANDA 213630HIKMA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 5MG BASE/ML0PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATE

FDA Submissions

UNKNOWN; ORIG1AP2022-11-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213630
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCHLORPERAZINE EDISYLATE","activeIngredients":"PROCHLORPERAZINE EDISYLATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-22
        )

)

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