ANDA 200909

DR REDDYS LABS SA

FDA Drug Application

Application #200909

Application Sponsors

ANDA 200909

DR REDDYS LABS SA

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

N/A; Not Applicable	ORIG	1	AP	2017-04-26
LABELING; Labeling	SUPPL	2	AP	2020-01-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-03-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	4	Null	7

TE Codes

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

CDER Filings

DR REDDYS LABS SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200909
            [companyName] => DR REDDYS LABS SA
            [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":"04\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/29\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-29
        )

)