TEVA PHARMS USA INC FDA Approval ANDA 211534

ANDA 211534

TEVA PHARMS USA INC

FDA Drug Application

Application #211534

Documents

Letter2019-09-30

Application Sponsors

ANDA 211534TEVA PHARMS USA INC

Marketing Status

None (Tentative Approval)001

Application Products

001FOR SUSPENSION;ORALEQ 10MG BASE/ML0SILDENAFIL CITRATESILDENAFIL CITRATE

FDA Submissions

UNKNOWN; ORIG1TA2019-08-01STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211534
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211534Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-29
        )

)

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