ANDA 203511

DR REDDYS LABS LTD

FDA Drug Application

Application #203511

Documents

• Letter: 2014-11-10

Application Sponsors

ANDA 203511

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 450MG BASE

0

VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-11-04
LABELING; Labeling	SUPPL	3	AP	2020-03-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-03-13	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203511
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALGANCICLOVIR HYDROCHLORIDE","activeIngredients":"VALGANCICLOVIR HYDROCHLORIDE","strength":"EQ 450MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/04\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203511Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/13\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/13\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/22\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-13
        )

)