ANDA 208699

GLENMARK PHARMS LTD

FDA Drug Application

Application #208699

Application Sponsors

ANDA 208699

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	10MG;10MG	0	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN
002	TABLET;ORAL	10MG;20MG	0	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN
003	TABLET;ORAL	10MG;40MG	0	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN
004	TABLET;ORAL	10MG;80MG	0	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-06-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-02-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208699
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EZETIMIBE AND SIMVASTATIN","activeIngredients":"EZETIMIBE; SIMVASTATIN","strength":"10MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EZETIMIBE AND SIMVASTATIN","activeIngredients":"EZETIMIBE; SIMVASTATIN","strength":"10MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EZETIMIBE AND SIMVASTATIN","activeIngredients":"EZETIMIBE; SIMVASTATIN","strength":"10MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EZETIMIBE AND SIMVASTATIN","activeIngredients":"EZETIMIBE; SIMVASTATIN","strength":"10MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-24
        )

)