ANDA 204868

ACTAVIS LABS FL INC

FDA Drug Application

Application #204868

Application Sponsors

ANDA 204868

ACTAVIS LABS FL INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	4MG	0	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE
002	TABLET, EXTENDED RELEASE;ORAL	8MG	0	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-04-29

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204868
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FESOTERODINE FUMARATE","activeIngredients":"FESOTERODINE FUMARATE","strength":"4MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FESOTERODINE FUMARATE","activeIngredients":"FESOTERODINE FUMARATE","strength":"8MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/11\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-11
        )

)