ANDA 201578

DR REDDYS LABS LTD

FDA Drug Application

Application #201578

Application Sponsors

ANDA 201578

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	1MG	0	SIROLIMUS	SIROLIMUS
002	TABLET;ORAL	2MG	0	SIROLIMUS	SIROLIMUS

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-10-27
LABELING; Labeling	SUPPL	2	AP	2016-01-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201578
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/14\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/14\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-01-14
        )

)