ANDA 211291

CIPLA

FDA Drug Application

Application #211291

Application Sponsors

ANDA 211291

CIPLA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	500MG	0	RANOLAZINE	RANOLAZINE
002	TABLET, EXTENDED RELEASE;ORAL	1GM	0	RANOLAZINE	RANOLAZINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-05-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-01-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211291
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/22\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-22
        )

)