BE PHARMS FDA Approval ANDA 216171

ANDA 216171

BE PHARMS

FDA Drug Application

Application #216171

Application Sponsors

ANDA 216171BE PHARMS

Marketing Status

None (Tentative Approval)001

Application Products

001INJECTABLE;INTRAVENOUSEQ 40MG BASE/VIAL0PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM

FDA Submissions

UNKNOWN; ORIG1TA2022-02-09STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAP

CDER Filings

BE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216171
            [companyName] => BE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"40MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/09\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-09
        )

)

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