PRECISION DOSE INC FDA Approval ANDA 207686

ANDA 207686

PRECISION DOSE INC

FDA Drug Application

Application #207686

Documents

Review2022-06-28

Application Sponsors

ANDA 207686PRECISION DOSE INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION5MG/VIAL0PHENTOLAMINE MESYLATEPHENTOLAMINE MESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2017-07-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

PRECISION DOSE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207686
            [companyName] => PRECISION DOSE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTOLAMINE MESYLATE","activeIngredients":"PHENTOLAMINE MESYLATE","strength":"5MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-14
        )

)

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