ANDA 214326

TEVA PHARMS USA INC

FDA Drug Application

Application #214326

Documents

• Letter: 2021-05-07

Application Sponsors

ANDA 214326

TEVA PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

100MG

0

TIOPRONIN

TIOPRONIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214326
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIOPRONIN","activeIngredients":"TIOPRONIN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214326Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-26
        )

)