BAMF FDA Approval ANDA 216126

ANDA 216126

BAMF

FDA Drug Application

Application #216126

Application Sponsors

ANDA 216126BAMF

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS10-200mCi/ML0SODIUM FLUORIDE F-18SODIUM FLUORIDE F-18

FDA Submissions

UNKNOWN; ORIG1AP2022-12-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

BAMF
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216126
            [companyName] => BAMF
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM FLUORIDE F-18","activeIngredients":"SODIUM FLUORIDE F-18","strength":"10-200mCi\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/06\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-06
        )

)

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