ANDA 206411

CADILA

FDA Drug Application

Application #206411

Application Sponsors

ANDA 206411

CADILA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

1.5%

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AT

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206411
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"1.5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/28\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-04-28
        )

)