MICRO LABS FDA Approval ANDA 207400

ANDA 207400

MICRO LABS

FDA Drug Application

Application #207400

Application Sponsors

ANDA 207400MICRO LABS

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUSEQ 30MG BASE/3ML (EQ 10MG BASE/ML)0CAFFEINE CITRATECAFFEINE CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2017-12-14STANDARD
LABELING; LabelingSUPPL3AP2020-11-12STANDARD
LABELING; LabelingSUPPL4AP2020-11-12STANDARD
LABELING; LabelingSUPPL5AP2020-11-12STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7
SUPPL4Null7
SUPPL5Null7

TE Codes

001PrescriptionAP

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207400
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAFFEINE CITRATE","activeIngredients":"CAFFEINE CITRATE","strength":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-14
        )

)

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