ANDA 203818

TARO

FDA Drug Application

Application #203818

Application Sponsors

ANDA 203818

TARO

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

1.5%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-11-26
LABELING; Labeling	SUPPL	7	AP	2021-04-30	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	7	Null	15

TE Codes

001

Prescription

AT

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203818
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1.5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/26\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/30\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/02\/2021","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-04-30
        )

)