ANDA 076201

DEXCEL LTD

FDA Drug Application

Application #076201

Application Sponsors

ANDA 076201

DEXCEL LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

100MG

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

	ORIG	1	AP	2002-11-06
LABELING; Labeling	SUPPL	3	AP	2003-10-23
LABELING; Labeling	SUPPL	5	AP	2006-03-13
LABELING; Labeling	SUPPL	6	AP	2006-11-29
LABELING; Labeling	SUPPL	8	AP	2009-07-31
LABELING; Labeling	SUPPL	9	AP	2010-07-06
LABELING; Labeling	SUPPL	10	AP	2014-12-14
LABELING; Labeling	SUPPL	27	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	8	Null	7
SUPPL	10	Null	8
SUPPL	27	Null	15

TE Codes

001

Prescription

AB

CDER Filings

DEXCEL LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76201
            [companyName] => DEXCEL LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)