ASPIRO FDA Approval ANDA 216413

ANDA 216413

ASPIRO

FDA Drug Application

Application #216413

Application Sponsors

ANDA 216413ASPIRO

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION500MG/VIAL0DAPTOMYCINDAPTOMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2022-09-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

ASPIRO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216413
            [companyName] => ASPIRO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-23
        )

)

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