ANDA 212485

TEVA PHARMS USA

FDA Drug Application

Application #212485

Documents

• Letter: 2019-12-04

Application Sponsors

ANDA 212485

TEVA PHARMS USA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

LOTION;TOPICAL

0.5%

0

IVERMECTIN

IVERMECTIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-11-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212485
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVERMECTIN","activeIngredients":"IVERMECTIN","strength":"0.5%","dosageForm":"LOTION;TOPICAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/19\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212485Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-19
        )

)