ANDA 075470

SUN PHARM INDUSTRIES

FDA Drug Application

Application #075470

Application Sponsors

ANDA 075470

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

DICLOFENAC POTASSIUM

DICLOFENAC POTASSIUM

FDA Submissions

	ORIG	1	AP	2002-02-21
LABELING; Labeling	SUPPL	9	AP	2006-07-28
LABELING; Labeling	SUPPL	10	AP	2006-10-13
LABELING; Labeling	SUPPL	11	AP	2021-04-30	STANDARD

Submissions Property Types

SUPPL

11

Null

31

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75470
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC POTASSIUM","activeIngredients":"DICLOFENAC POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICLOFENAC POTASSIUM","submission":"DICLOFENAC POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)