ANDA 076561

AMICI

FDA Drug Application

Application #076561

Application Sponsors

ANDA 076561

AMICI

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG	0	DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM
002	TABLET;ORAL	25MG	0	CATAFLAM	DICLOFENAC POTASSIUM

FDA Submissions

	ORIG	1	AP	2004-03-18
LABELING; Labeling	SUPPL	2	AP	2006-03-17
LABELING; Labeling	SUPPL	6	AP	2009-02-25
LABELING; Labeling	SUPPL	7	AP	2010-05-12
LABELING; Labeling	SUPPL	8	AP	2014-12-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-05-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-05-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2021-04-12	UNKNOWN
LABELING; Labeling	SUPPL	12	AP	2021-04-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-05-17	STANDARD

Submissions Property Types

SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	13	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMICI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76561
            [companyName] => AMICI
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC POTASSIUM","activeIngredients":"DICLOFENAC POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICLOFENAC POTASSIUM","submission":"DICLOFENAC POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)