ANDA 205166

HETERO LABS LTD V

FDA Drug Application

Application #205166

Application Sponsors

ANDA 205166

HETERO LABS LTD V

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 450MG BASE

0

VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-03-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-08-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-08-18	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15
SUPPL	13	Null	7
SUPPL	14	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD V

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205166
            [companyName] => HETERO LABS LTD V
            [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":"03\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/12\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-12
        )

)