ANDA 202727

WOCKHARDT LTD

FDA Drug Application

Application #202727

Documents

• Review: 2015-07-20
• Letter: 2012-05-22

Application Sponsors

ANDA 202727

WOCKHARDT LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE, DELAYED REL PELLETS;ORAL

15MG

0

LANSOPRAZOLE

LANSOPRAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2012-05-18

Submissions Property Types

ORIG

1

Null

15

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202727
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202727s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/202727Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-05-18
        )

)