ANDA 212234

AJANTA PHARMA LTD

FDA Drug Application

Application #212234

Application Sponsors

ANDA 212234

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 450MG BASE

0

VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-06-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-06-04	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-08-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	19	Null	7

TE Codes

001

Prescription

AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212234
            [companyName] => AJANTA PHARMA 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":"12\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-26
        )

)