APOTEX FDA Approval ANDA 204439

ANDA 204439

APOTEX

FDA Drug Application

Application #204439

Application Sponsors

ANDA 204439APOTEX

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUS50MG/VIAL0TIGECYCLINETIGECYCLINE

FDA Submissions

UNKNOWN; ORIG1AP2018-12-21
LABELING; LabelingSUPPL3AP2021-02-01STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7

TE Codes

001PrescriptionAP

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204439
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGECYCLINE","activeIngredients":"TIGECYCLINE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)

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