ANDA 209484

HI TECH

FDA Drug Application

Application #209484

Application Sponsors

ANDA 209484

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

1%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-21	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-02-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209484
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-21
        )

)