ANDA 205575

ALEMBIC PHARMS LTD

FDA Drug Application

Application #205575

Application Sponsors

ANDA 205575

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE
002	TABLET;ORAL	10MG	0	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-05-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-10-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205575
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOLIFENACIN SUCCINATE","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SOLIFENACIN SUCCINATE","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-20
        )

)