ANDA 205769

PAR PHARM INC

FDA Drug Application

Application #205769

Documents

• Letter: 2019-04-24

Application Sponsors

ANDA 205769

PAR PHARM INC

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205769
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE","activeIngredients":"ALISKIREN HEMIFUMARATE;HYDROCHLOROTHIAZIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205769Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-04
        )

)