ANDA 213306

GRANULES PHARMS

FDA Drug Application

Application #213306

Application Sponsors

ANDA 213306

GRANULES PHARMS

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

50MG/ML

0

VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-01-31	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-06-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

GRANULES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213306
            [companyName] => GRANULES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALGANCICLOVIR HYDROCHLORIDE","activeIngredients":"VALGANCICLOVIR HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-31
        )

)