ANDA 206336

PAR PHARM INC

FDA Drug Application

Application #206336

Documents

• Letter: 2015-09-10

Application Sponsors

ANDA 206336

PAR PHARM INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

1.1GM

0

BALSALAZIDE DISODIUM

BALSALAZIDE DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-09-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206336
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BALSALAZIDE DISODIUM","activeIngredients":"BALSALAZIDE DISODIUM","strength":"1.1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206336Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-08
        )

)