ANDA 211534

TEVA PHARMS USA INC

FDA Drug Application

Application #211534

Documents

• Letter: 2019-09-30

Application Sponsors

ANDA 211534

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

FOR SUSPENSION;ORAL

EQ 10MG BASE/ML

0

SILDENAFIL CITRATE

SILDENAFIL CITRATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-08-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

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
        )

)