ANDA 205959

PAR PHARM

FDA Drug Application

Application #205959

Documents

• Letter: 2016-08-22

Application Sponsors

ANDA 205959

PAR PHARM

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

002

TABLET;ORAL

5MG

0

SAXAGLIPTIN

SAXAGLIPTIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-08-17

STANDARD

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205959
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAXAGLIPTIN","activeIngredients":"SAXAGLIPTIN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SAXAGLIPTIN","activeIngredients":"SAXAGLIPTIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205959Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-17
        )

)