TORRENT FDA Approval ANDA 207786

ANDA 207786

TORRENT

FDA Drug Application

Application #207786

Application Sponsors

ANDA 207786TORRENT

Marketing Status

Discontinued001

Application Products

001SOLUTION;ORAL10GM/15ML0LACTULOSELACTULOSE

FDA Submissions

UNKNOWN; ORIG1AP2018-06-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2021-09-08UNKNOWN

Submissions Property Types

ORIG1Null7
SUPPL2Null15

TE Codes

001PrescriptionAA

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207786
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACTULOSE","activeIngredients":"LACTULOSE","strength":"10GM\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-11
        )

)

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