BAYER FDA Approval NDA 020204

Application #020204

Documents

Letter	2002-03-19
Letter	2002-08-30
Letter	2005-05-05
Letter	2006-01-20
Letter	2008-11-26
Letter	2011-02-24
Letter	2013-02-08
Label	2005-05-05
Label	2016-06-17
Other Important Information from FDA	2005-07-28
Letter	2001-03-06
Letter	2004-03-24
Letter	2009-04-21
Letter	2010-11-08
Letter	2011-04-11
Letter	2012-03-19
Letter	2012-03-19
Letter	2013-01-07
Letter	2013-04-23
Label	2014-01-14
Label	2013-11-21
Label	2017-08-24
Letter	2017-08-25
Letter	2017-09-19
Label	2017-09-21
Label	2018-03-28
Letter	2018-03-29
Letter	2018-04-01
Label	2018-04-01
Letter	2018-06-14
Letter	2018-06-14
Label	2018-06-20
Label	2018-06-20
Letter	2018-07-26
Label	2018-08-03
Letter	2018-08-30
Label	2018-08-30
Letter	2018-10-01
Label	2018-10-15
Label	2019-01-04
Letter	2019-01-04
Label	2019-02-06
Letter	2019-02-13
Letter	2019-05-15
Label	2019-05-15
Letter	2019-05-15
Letter	2019-07-05
Label	2019-07-05
Letter	2019-07-24
Label	2019-07-24
Letter	2019-08-13
Label	2019-08-12
Letter	2020-03-04
Label	2020-03-04
Label	2020-04-24
Letter	2020-04-24
Label	2020-05-11
Letter	2020-05-11
Letter	2020-11-02
Letter	2021-01-04
Letter	2021-01-04
Letter	2021-01-04
Letter	2021-01-04
Label	2021-02-23
Letter	2021-04-05
Label	2021-04-19
Label	2021-04-19
Label	2021-04-19
Label	2021-04-19
Label	2021-04-23
Letter	2022-03-11
Label	2022-03-15

Application Sponsors

NDA 020204

BAYER

Marketing Status

Over-the-counter

002

Application Products

002

TABLET;ORAL

220MG

ALEVE

NAPROXEN SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1994-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-11-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2001-03-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-03-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	2000-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-08-30	STANDARD
LABELING; Labeling	SUPPL	19	AP	2004-03-22	STANDARD
LABELING; Labeling	SUPPL	21	AP	2005-05-04	STANDARD
LABELING; Labeling	SUPPL	23	AP	2006-01-06	STANDARD
LABELING; Labeling	SUPPL	31	AP	2008-11-24	STANDARD
LABELING; Labeling	SUPPL	32	AP	2009-04-15	STANDARD
LABELING; Labeling	SUPPL	35	AP	2010-11-03	STANDARD
LABELING; Labeling	SUPPL	36	AP	2011-02-18	STANDARD
LABELING; Labeling	SUPPL	37	AP	2011-04-08	STANDARD
LABELING; Labeling	SUPPL	38	AP	2013-02-07	STANDARD
LABELING; Labeling	SUPPL	39	AP	2012-03-15	STANDARD
LABELING; Labeling	SUPPL	40	AP	2012-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2012-11-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2013-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2013-01-07	STANDARD
LABELING; Labeling	SUPPL	44	AP	2013-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2015-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2016-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2016-07-28	STANDARD
LABELING; Labeling	SUPPL	51	AP	2017-08-22	STANDARD
LABELING; Labeling	SUPPL	52	AP	2017-09-14	STANDARD
LABELING; Labeling	SUPPL	53	AP	2018-03-27	STANDARD
LABELING; Labeling	SUPPL	54	AP	2018-03-29	STANDARD
LABELING; Labeling	SUPPL	55	AP	2018-06-08	STANDARD
LABELING; Labeling	SUPPL	56	AP	2018-06-11	STANDARD
LABELING; Labeling	SUPPL	57	AP	2018-07-25	STANDARD
LABELING; Labeling	SUPPL	58	AP	2018-08-28	STANDARD
LABELING; Labeling	SUPPL	59	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	61	AP	2019-01-28	STANDARD
LABELING; Labeling	SUPPL	62	AP	2019-01-03	STANDARD
LABELING; Labeling	SUPPL	63	AP	2019-05-13	STANDARD
LABELING; Labeling	SUPPL	64	AP	2019-05-13	STANDARD
LABELING; Labeling	SUPPL	65	AP	2019-05-13	STANDARD
LABELING; Labeling	SUPPL	66	AP	2019-07-02	STANDARD
LABELING; Labeling	SUPPL	67	AP	2019-07-23	STANDARD
LABELING; Labeling	SUPPL	68	AP	2019-08-07	STANDARD
LABELING; Labeling	SUPPL	70	AP	2020-03-02	STANDARD
LABELING; Labeling	SUPPL	71	AP	2020-04-23	STANDARD
LABELING; Labeling	SUPPL	72	AP	2020-05-08	STANDARD
LABELING; Labeling	SUPPL	76	AP	2020-10-28	STANDARD
LABELING; Labeling	SUPPL	77	AP	2020-12-31	STANDARD
LABELING; Labeling	SUPPL	78	AP	2020-12-31	STANDARD
LABELING; Labeling	SUPPL	79	AP	2020-12-31	STANDARD
LABELING; Labeling	SUPPL	80	AP	2020-12-31	STANDARD
LABELING; Labeling	SUPPL	81	AP	2021-04-01	STANDARD
LABELING; Labeling	SUPPL	83	AP	2022-03-10	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	9
SUPPL	35	Null	6
SUPPL	36	Null	6
SUPPL	37	Null	6
SUPPL	38	Null	6
SUPPL	39	Null	6
SUPPL	40	Null	6
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	15
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	51	Null	7
SUPPL	52	Null	7
SUPPL	53	Null	15
SUPPL	54	Null	6
SUPPL	55	Null	6
SUPPL	56	Null	7
SUPPL	57	Null	7
SUPPL	58	Null	15
SUPPL	59	Null	6
SUPPL	61	Null	15
SUPPL	62	Null	6
SUPPL	63	Null	6
SUPPL	64	Null	7
SUPPL	65	Null	7
SUPPL	66	Null	15
SUPPL	67	Null	6
SUPPL	68	Null	6
SUPPL	70	Null	15
SUPPL	71	Null	6
SUPPL	72	Null	6
SUPPL	76	Null	7
SUPPL	77	Null	15
SUPPL	78	Null	6
SUPPL	79	Null	6
SUPPL	80	Null	7
SUPPL	81	Null	7
SUPPL	83	Null	7

CDER Filings

BAYER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20204
            [companyName] => BAYER
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALEVE","activeIngredients":"NAPROXEN SODIUM","strength":"220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/08\/2020","submission":"SUPPL-72","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020204Orig1s072Lbledt.pdf\"}]","notes":""},{"actionDate":"04\/23\/2020","submission":"SUPPL-71","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020204Orig1s071lbl.pdf\"}]","notes":""},{"actionDate":"03\/02\/2020","submission":"SUPPL-70","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020204Orig1s070lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2019","submission":"SUPPL-68","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020204Orig1s068lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2019","submission":"SUPPL-67","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020204Orig1s067lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2019","submission":"SUPPL-66","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020204Orig1s066lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2019","submission":"SUPPL-64","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020204Orig1s064lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2019","submission":"SUPPL-61","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020204Orig1s061lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2019","submission":"SUPPL-62","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020204Orig1s062lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2018","submission":"SUPPL-59","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020204Orig1s059lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2018","submission":"SUPPL-58","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020204s058lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2018","submission":"SUPPL-57","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020204Orig1s057Lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2018","submission":"SUPPL-56","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020204Orig1s056lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2018","submission":"SUPPL-55","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020204Orig1s055lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2018","submission":"SUPPL-54","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020204Orig1s054lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2018","submission":"SUPPL-53","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020204Orig1s053lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2017","submission":"SUPPL-52","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020204Orig1s052lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2017","submission":"SUPPL-51","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020204Orig1s051lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2016","submission":"SUPPL-48","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020204Orig1s048Lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"04\/18\/2013","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020204Orig1s044lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2013","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020204Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2005","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020204s021lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALEVE","submission":"NAPROXEN SODIUM","actionType":"220MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-08
        )

)

NDA 020204

BAYER

FDA Drug Application

Application #020204

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

BAYER