ANDA 202027

APOTEX INC

FDA Drug Application

Application #202027

Application Sponsors

ANDA 202027

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

1.5%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2017-10-20
LABELING; Labeling	SUPPL	4	AP	2017-10-20	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AT

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202027
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1.5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/20\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/20\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-10-20
        )

)