ANDA 207681

ALEMBIC PHARMS LTD

FDA Drug Application

Application #207681

Application Sponsors

ANDA 207681

ALEMBIC PHARMS LTD

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

2017-12-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207681
            [companyName] => ALEMBIC PHARMS LTD
            [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":"12\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-08
        )

)