ANDA 205209

TORRENT

FDA Drug Application

Application #205209

Application Sponsors

ANDA 205209

TORRENT

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 7.5MG BASE	0	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 15MG BASE	0	DARIFENACIN HYDROBROMIDE	DARIFENACIN HYDROBROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205209
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DARIFENACIN HYDROBROMIDE","activeIngredients":"DARIFENACIN HYDROBROMIDE","strength":"EQ 7.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DARIFENACIN HYDROBROMIDE","activeIngredients":"DARIFENACIN HYDROBROMIDE","strength":"EQ 15MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-17
        )

)