ANDA 204765

TORRENT

FDA Drug Application

Application #204765

Application Sponsors

ANDA 204765

TORRENT

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

1.5MG/5ML;5MG/5ML

0

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-06-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204765
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE","activeIngredients":"HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE","strength":"1.5MG\/5ML;5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/28\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-06-28
        )

)