ANDA 072267

XSPIRE PHARMA

FDA Drug Application

Application #072267

Application Sponsors

ANDA 072267

XSPIRE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE

0

FENOPROFEN CALCIUM

FENOPROFEN CALCIUM

FDA Submissions

	ORIG	1	AP	1988-06-08
LABELING; Labeling	SUPPL	3	AP	1988-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-10-31
LABELING; Labeling	SUPPL	8	AP	1991-10-31
LABELING; Labeling	SUPPL	9	AP	1991-10-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-06-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-02-05
LABELING; Labeling	SUPPL	15	AP	2006-03-13
LABELING; Labeling	SUPPL	16	AP	2006-05-16
LABELING; Labeling	SUPPL	19	AP	2007-12-20
LABELING; Labeling	SUPPL	22	AP	2015-04-24	STANDARD
LABELING; Labeling	SUPPL	23	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	25	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	1
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	22	Null	7
SUPPL	23	Null	15
SUPPL	25	Null	7

CDER Filings

XSPIRE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72267
            [companyName] => XSPIRE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOPROFEN CALCIUM","activeIngredients":"FENOPROFEN CALCIUM","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FENOPROFEN CALCIUM","submission":"FENOPROFEN CALCIUM","actionType":"EQ 600MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)