BE PHARMS FDA Approval ANDA 212513

ANDA 212513

BE PHARMS

FDA Drug Application

Application #212513

Application Sponsors

ANDA 212513BE PHARMS

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUS500MG/VIAL0DAPTOMYCINDAPTOMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2019-06-26STANDARD
LABELING; LabelingSUPPL3AP2022-11-13STANDARD
LABELING; LabelingSUPPL5AP2022-11-13STANDARD
LABELING; LabelingSUPPL7AP2022-11-13STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL5Null7
SUPPL7Null7

TE Codes

001PrescriptionAP

CDER Filings

BE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212513
            [companyName] => BE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-26
        )

)

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