ANDA 211436

TEVA PHARMS USA

FDA Drug Application

Application #211436

Documents

• Letter: 2018-11-16

Application Sponsors

ANDA 211436

TEVA PHARMS USA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

300MG

0

MIFEPRISTONE

MIFEPRISTONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-10-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211436
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIFEPRISTONE","activeIngredients":"MIFEPRISTONE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211436Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-03
        )

)