ANDA 074986

MICRO LABS USA

FDA Drug Application

Application #074986

Documents

• Label: 2004-06-02
• Letter: 1999-02-26
• Review: 1999-02-26

Application Sponsors

ANDA 074986

MICRO LABS USA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	1999-02-26
LABELING; Labeling	SUPPL	2	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	7

CDER Filings

MICRO LABS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74986
            [companyName] => MICRO LABS USA
            [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] => [{"actionDate":"02\/26\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/74986_Doclofenec%20Sodium_prntlbl.pdf\"}]","notes":""}]
            [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] => 1999-02-26
        )

)