UBI FDA Approval ANDA 211263

ANDA 211263

UBI

FDA Drug Application

Application #211263

Application Sponsors

ANDA 211263UBI

Marketing Status

Prescription001
Prescription002

Application Products

001POWDER;INTRAVENOUS50MG/VIAL0CASPOFUNGIN ACETATECASPOFUNGIN ACETATE
002POWDER;INTRAVENOUS70MG/VIAL0CASPOFUNGIN ACETATECASPOFUNGIN ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2021-10-01STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

UBI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211263
            [companyName] => UBI
            [docInserts] => ["",""]
            [products] => [{"drugName":"CASPOFUNGIN ACETATE","activeIngredients":"CASPOFUNGIN ACETATE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CASPOFUNGIN ACETATE","activeIngredients":"CASPOFUNGIN ACETATE","strength":"70MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-01
        )

)

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