ANDA 207740

DR REDDYS

FDA Drug Application

Application #207740

Documents

• Letter: 2018-11-15

Application Sponsors

ANDA 207740

DR REDDYS

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

20MG

0

OMEPRAZOLE

OMEPRAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207740
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207740Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-05
        )

)