ANDA 201946

PAR PHARM

FDA Drug Application

Application #201946

Documents

• Letter: 2016-07-20

Application Sponsors

ANDA 201946

PAR PHARM

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

20MG;1.1GM

0

OMEPRAZOLE AND SODIUM BICARBONATE

OMEPRAZOLE; SODIUM BICARBONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-07-15

Submissions Property Types

ORIG

1

Null

7

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201946
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201946Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-07-15
        )

)