NDA 017581

ATNAHS PHARMA US

FDA Drug Application

Application #017581

Documents

• Letter: 2003-05-29
• Letter: 2004-11-16
• Letter: 2007-09-25
• Letter: 2013-03-26
• Letter: 2016-05-11
• Label: 2004-11-16
• Label: 2006-03-14
• Label: 2006-01-25
• Label: 2007-09-26
• Label: 2008-07-29
• Letter: 2004-11-16
• Letter: 2006-03-23
• Letter: 2006-01-30
• Letter: 2007-04-25
• Letter: 2008-07-30
• Label: 2004-11-16
• Label: 2013-03-26
• Label: 2016-05-11
• Review: 2007-04-11
• Label: 2017-03-13
• Letter: 2017-03-14
• Letter: 2019-07-23
• Label: 2019-07-23
• Medication Guide: 2019-07-23
• Label: 2021-04-29
• Medication Guide: 2021-04-29
• Letter: 2021-04-29

Application Sponsors

NDA 017581

ATNAHS PHARMA US

Marketing Status

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

Application Products

002	TABLET;ORAL	250MG	1	NAPROSYN	NAPROXEN
003	TABLET;ORAL	375MG	1	NAPROSYN	NAPROXEN
004	TABLET;ORAL	500MG	1	NAPROSYN	NAPROXEN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1976-03-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	1976-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1976-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1978-08-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1978-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1979-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1978-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1979-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1979-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1979-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1979-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1979-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1979-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1979-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1980-04-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1980-03-21	STANDARD
LABELING; Labeling	SUPPL	27	AP	1980-05-13
LABELING; Labeling	SUPPL	30	AP	1980-09-12
LABELING; Labeling	SUPPL	31	AP	1982-04-15
LABELING; Labeling	SUPPL	33	AP	1981-10-13
LABELING; Labeling	SUPPL	34	AP	1981-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1981-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1981-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1982-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1981-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1981-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1981-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1982-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1981-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1982-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1982-03-31	STANDARD
LABELING; Labeling	SUPPL	46	AP	1983-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1983-01-13	STANDARD
LABELING; Labeling	SUPPL	49	AP	1982-12-03
LABELING; Labeling	SUPPL	50	AP	1982-12-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1988-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1985-04-23	STANDARD
LABELING; Labeling	SUPPL	54	AP	1983-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1985-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1985-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1986-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1985-04-23	STANDARD
EFFICACY; Efficacy	SUPPL	65	AP	1987-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1986-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1986-06-10	STANDARD
LABELING; Labeling	SUPPL	69	AP	1985-09-24
LABELING; Labeling	SUPPL	72	AP	1986-12-16
EFFICACY; Efficacy	SUPPL	73	AP	1987-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	1989-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	86	AP	1991-10-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	1994-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	1991-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	89	AP	1992-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	1992-08-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	95	AP	1994-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	96	AP	1994-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	97	AP	1994-12-08	STANDARD
LABELING; Labeling	SUPPL	98	AP	2003-04-14	STANDARD
LABELING; Labeling	SUPPL	99	AP	2004-11-10	STANDARD
LABELING; Labeling	SUPPL	100	AP	2004-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	101	AP	2000-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	102	AP	2001-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	103	AP	2002-02-22	STANDARD
LABELING; Labeling	SUPPL	105	AP	2006-03-10	STANDARD
LABELING; Labeling	SUPPL	106	AP	2006-01-24	STANDARD
LABELING; Labeling	SUPPL	107	AP	2007-04-19	STANDARD
LABELING; Labeling	SUPPL	108	AP	2007-09-20	STANDARD
LABELING; Labeling	SUPPL	110	AP	2008-07-25	STANDARD
LABELING; Labeling	SUPPL	111	AP	2013-03-22	STANDARD
LABELING; Labeling	SUPPL	112	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	113	AP	2017-03-10	STANDARD
LABELING; Labeling	SUPPL	114	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	115	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	48	Null	0
SUPPL	51	Null	0
SUPPL	53	Null	0
SUPPL	60	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	80	Null	0
SUPPL	86	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	89	Null	0
SUPPL	93	Null	0
SUPPL	95	Null	0
SUPPL	96	Null	0
SUPPL	97	Null	0
SUPPL	101	Null	0
SUPPL	102	Null	0
SUPPL	103	Null	0
SUPPL	111	Null	15
SUPPL	112	Null	15
SUPPL	113	Null	6
SUPPL	114	Null	7
SUPPL	115	Null	7

TE Codes

004

Prescription

AB

CDER Filings

ATNAHS PHARMA US

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(
    [0] => Array
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            [ApplNo] => 17581
            [companyName] => ATNAHS PHARMA US
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/017581s115,018164s065,020067s064lbl.pdf#page=23"]
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            [labels] => [{"actionDate":"04\/28\/2021","submission":"SUPPL-115","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/017581s115,018164s065,020067s064lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2019","submission":"SUPPL-114","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/017581s114,018164s064,020067s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2017","submission":"SUPPL-113","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017581s113,018164s063,020067s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-112","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017581s112,018164s062,020067s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-112","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017581s112,018164s062,020067s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2013","submission":"SUPPL-111","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/017581s111,018164s061,018965s020,020067s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2008","submission":"SUPPL-110","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017581s110,18164s60,18965s18,20067s17lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2007","submission":"SUPPL-108","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/017581s108,18164s58,18965s16,20067s14lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2006","submission":"SUPPL-105","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"01\/24\/2006","submission":"SUPPL-106","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/017581s106,018164s056,018965s014,020067s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2004","submission":"SUPPL-100","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2004","submission":"SUPPL-99","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NAPROSYN","submission":"NAPROXEN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NAPROSYN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NAPROSYN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-04-28
        )

)