ANDA 077863

UNIQUE PHARM LABS

FDA Drug Application

Application #077863

Application Sponsors

ANDA 077863

UNIQUE PHARM LABS

Marketing Status

• Prescription: 003

Application Products

003

TABLET, DELAYED RELEASE;ORAL

75MG

0

DICLOFENAC SODIUM

DICLOFENAC SODIUM

FDA Submissions

	ORIG	1	AP	2007-06-08
LABELING; Labeling	SUPPL	3	AP	2009-08-04
LABELING; Labeling	SUPPL	5	AP	2011-03-17
LABELING; Labeling	SUPPL	6	AP	2014-10-22
LABELING; Labeling	SUPPL	8	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-03-29	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	7
SUPPL	17	Null	7

TE Codes

003

Prescription

AB

CDER Filings

UNIQUE PHARM LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77863
            [companyName] => UNIQUE PHARM LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC SODIUM","activeIngredients":"DICLOFENAC SODIUM","strength":"75MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICLOFENAC SODIUM","submission":"DICLOFENAC SODIUM","actionType":"75MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)