ANDA 206661

TORRENT

FDA Drug Application

Application #206661

Application Sponsors

ANDA 206661

TORRENT

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML;60MG/5ML

0

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206661
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"5MG\/5ML;60MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-23
        )

)