ANDA 203016

TORRENT

FDA Drug Application

Application #203016

Application Sponsors

ANDA 203016

TORRENT

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	2MG	0	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE
002	CAPSULE, EXTENDED RELEASE;ORAL	4MG	0	TOLTERODINE TARTRATE	TOLTERODINE TARTRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-08-11
LABELING; Labeling	SUPPL	3	AP	2020-03-09	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203016
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"2MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOLTERODINE TARTRATE","activeIngredients":"TOLTERODINE TARTRATE","strength":"4MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/09\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-09
        )

)