NDA 015034

SHIONOGI INC

FDA Drug Application

Application #015034

Documents

• Letter: 2006-01-20
• Letter: 2008-03-17
• Letter: 2016-05-11
• Label: 2016-05-11
• Review: 2008-08-04
• Label: 2006-01-20
• Label: 2008-03-07
• Review: 2008-08-11
• Medication Guide: 2009-11-20
• Letter: 2021-04-29
• Label: 2021-04-29
• Medication Guide: 2021-04-29

Application Sponsors

NDA 015034

SHIONOGI INC

Marketing Status

• Prescription: 003

Application Products

003

CAPSULE;ORAL

250MG

1

PONSTEL

MEFENAMIC ACID

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1967-03-28	STANDARD
LABELING; Labeling	SUPPL	8	AP	1975-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1977-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1977-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1981-02-17	STANDARD
LABELING; Labeling	SUPPL	13	AP	1981-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1981-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1981-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1981-03-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1981-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1982-01-26	STANDARD
LABELING; Labeling	SUPPL	21	AP	1983-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1983-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1984-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1986-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1984-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1989-06-14	STANDARD
LABELING; Labeling	SUPPL	28	AP	1989-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1993-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1996-04-05	STANDARD
LABELING; Labeling	SUPPL	32	AP	1998-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1998-09-01	STANDARD
LABELING; Labeling	SUPPL	34	AP	2001-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2001-07-31	STANDARD
LABELING; Labeling	SUPPL	39	AP	2006-01-18	STANDARD
LABELING; Labeling	SUPPL	40	AP	2008-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2009-08-03	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2015-01-05	STANDARD
LABELING; Labeling	SUPPL	44	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	45	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	15
SUPPL	45	Null	15

TE Codes

003

Prescription

AB

CDER Filings

AVION PHARMS

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(
    [0] => Array
        (
            [ApplNo] => 15034
            [companyName] => AVION PHARMS
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088692.pdf"]
            [products] => [{"drugName":"PONSTEL","activeIngredients":"MEFENAMIC ACID","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/09\/2016","submission":"SUPPL-44","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/015034s044lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/015034s044lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/015034s044lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2008","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/015034s040lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2006","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/015034s039lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PONSTEL","submission":"MEFENAMIC ACID","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-05-09
        )

)