ANDA 074432

PLIVA

FDA Drug Application

Application #074432

Documents

• Letter: 1999-07-29

Application Sponsors

ANDA 074432

PLIVA

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	TABLET, DELAYED RELEASE;ORAL	50MG	0	DICLOFENAC SODIUM	DICLOFENAC SODIUM
003	TABLET, DELAYED RELEASE;ORAL	75MG	0	DICLOFENAC SODIUM	DICLOFENAC SODIUM

FDA Submissions

	ORIG	1	AP	1999-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-06-29
LABELING; Labeling	SUPPL	3	AP	2002-03-25
LABELING; Labeling	SUPPL	9	AP	2006-02-23
LABELING; Labeling	SUPPL	13	AP	2007-01-08
LABELING; Labeling	SUPPL	17	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	17	Null	7

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74432
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"50MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"75MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"50MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"75MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)