ANDA 202357

DR REDDYS LABS LTD

FDA Drug Application

Application #202357

Documents

• Review: 2015-03-09

Application Sponsors

ANDA 202357

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 80MG BASE

0

ATORVASTATIN CALCIUM

ATORVASTATIN CALCIUM

FDA Submissions

	ORIG	1	AP	2012-07-17
LABELING; Labeling	SUPPL	2	AP	2012-12-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-11-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-05-04	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-05-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-05-04	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-05-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	15
SUPPL	13	Null	31
SUPPL	14	Null	15
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202357
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 80MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/17\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/202357Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/22\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/06\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/04\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/29\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/27\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-22
        )

)