ANDA 200895

HETERO LABS LTD III

FDA Drug Application

Application #200895

Application Sponsors

ANDA 200895

HETERO LABS LTD III

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	5MG	0	SIMVASTATIN	SIMVASTATIN
002	TABLET;ORAL	10MG	0	SIMVASTATIN	SIMVASTATIN
003	TABLET;ORAL	20MG	0	SIMVASTATIN	SIMVASTATIN
004	TABLET;ORAL	40MG	0	SIMVASTATIN	SIMVASTATIN
005	TABLET;ORAL	80MG	0	SIMVASTATIN	SIMVASTATIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-11-25
LABELING; Labeling	SUPPL	2	AP	2015-11-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-08-31	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-08-31	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-08-31	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7
SUPPL	8	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7

TE Codes

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

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200895
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/05\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-11-05
        )

)