ANDA 211045

POLYGEN PHARMS

FDA Drug Application

Application #211045

Application Sponsors

ANDA 211045

POLYGEN PHARMS

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

2020-01-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

POLYGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211045
            [companyName] => POLYGEN PHARMS
            [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":"01\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-06
        )

)