MICRO LABS FDA Approval ANDA 214879

ANDA 214879

MICRO LABS

FDA Drug Application

Application #214879

Application Sponsors

ANDA 214879MICRO LABS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION20MG/ML0SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-24STANDARD
LABELING; LabelingSUPPL4AP2022-03-31STANDARD
LABELING; LabelingSUPPL5AP2022-03-31STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null15
SUPPL5Null15

TE Codes

001PrescriptionAP

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214879
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-24
        )

)

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