ANDA 206876

DR REDDYS

FDA Drug Application

Application #206876

Application Sponsors

ANDA 206876

DR REDDYS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 450MG BASE

0

VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-12	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-05-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-05-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206876
            [companyName] => DR REDDYS
            [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":"12\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/23\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-23
        )

)