ACCORD HLTHCARE FDA Approval ANDA 212667

ANDA 212667

ACCORD HLTHCARE

FDA Drug Application

Application #212667

Documents

Letter2019-08-07

Application Sponsors

ANDA 212667ACCORD HLTHCARE

Marketing Status

Prescription001

Application Products

001POWDER;IV (INFUSION)350MG/VIAL0DAPTOMYCINDAPTOMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2019-07-12STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212667
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"350MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212667Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-12
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.