NDA 017604

XSPIRE PHARMA

FDA Drug Application

Application #017604

Documents

• Letter: 2007-08-14
• Letter: 2009-07-23
• Label: 2006-01-20
• Label: 2007-08-14
• Label: 2009-07-24
• Label: 2016-05-11
• Letter: 2006-01-20
• Letter: 2016-05-11
• Medication Guide: 2009-11-19
• Letter: 2021-04-29
• Label: 2021-05-03

Application Sponsors

NDA 017604

XSPIRE PHARMA

Marketing Status

• Discontinued: 002
• Prescription: 003
• Prescription: 004

Application Products

002	CAPSULE;ORAL	EQ 300MG BASE	0	NALFON	FENOPROFEN CALCIUM
003	CAPSULE;ORAL	EQ 200MG BASE	1	NALFON	FENOPROFEN CALCIUM
004	CAPSULE;ORAL	EQ 400MG BASE	1	NALFON	FENOPROFEN CALCIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1976-03-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1976-09-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1977-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1978-10-24	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	1980-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1980-10-15	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1983-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1980-05-06	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1981-07-14
LABELING; Labeling	SUPPL	16	AP	1983-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-07-29	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1983-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1987-12-11	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1986-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1987-07-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1987-07-15	PRIORITY
LABELING; Labeling	SUPPL	27	AP	1995-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1994-04-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1996-01-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1997-12-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1998-04-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1998-09-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1999-11-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2001-08-21	PRIORITY
LABELING; Labeling	SUPPL	40	AP	2006-01-18	STANDARD
LABELING; Labeling	SUPPL	41	AP	2007-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2009-07-21	N/A
LABELING; Labeling	SUPPL	46	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	51	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	46	Null	15
SUPPL	51	Null	7

TE Codes

004

Prescription

AB

CDER Filings

XSPIRE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17604
            [companyName] => XSPIRE PHARMA
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088655.pdf"]
            [products] => [{"drugName":"NALFON","activeIngredients":"FENOPROFEN CALCIUM","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NALFON","activeIngredients":"FENOPROFEN CALCIUM","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NALFON","activeIngredients":"FENOPROFEN CALCIUM","strength":"EQ 400MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/09\/2016","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017604s046lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017604s046lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-46","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017604s046lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2009","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017604s043lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2009","submission":"SUPPL-43","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017604s043lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2007","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/017604s041lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2006","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/017604s040lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NALFON","submission":"FENOPROFEN CALCIUM","actionType":"EQ 300MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NALFON","submission":"FENOPROFEN CALCIUM","actionType":"EQ 200MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NALFON","submission":"FENOPROFEN CALCIUM","actionType":"EQ 400MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-05-09
        )

)