ANDA 205220

ACTAVIS LABS FL INC

FDA Drug Application

Application #205220

Documents

• Letter: 2016-07-22

Application Sponsors

ANDA 205220

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

50MG/ML

0

VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-07-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-03-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-03-12	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205220
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALGANCICLOVIR HYDROCHLORIDE","activeIngredients":"VALGANCICLOVIR HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205220Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/12\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/12\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-12
        )

)