NDA 021428

TAKEDA PHARMS USA

FDA Drug Application

Application #021428

Documents

• Letter: 2003-08-15
• Letter: 2006-04-13
• Letter: 2007-07-05
• Letter: 2008-04-23
• Letter: 2010-05-17
• Letter: 2011-06-03
• Letter: 2011-05-25
• Letter: 2012-10-02
• Letter: 2012-05-09
• Label: 2002-08-30
• Label: 2007-06-27
• Label: 2008-11-07
• Label: 2009-08-13
• Label: 2010-09-10
• Label: 2011-11-01
• Label: 2012-05-07
• Review: 2008-07-31
• Other Important Information from FDA: 2011-12-20
• Letter: 2002-08-30
• Letter: 2004-06-23
• Letter: 2008-10-29
• Letter: 2009-11-12
• Letter: 2011-10-31
• Letter: 2015-12-18
• Letter: 2014-12-24
• Label: 2004-12-21
• Label: 2006-04-13
• Label: 2010-05-17
• Label: 2011-06-07
• Label: 2011-05-26
• Label: 2012-10-01
• Label: 2015-12-17
• Label: 2014-12-29
• Review: 2005-06-23
• Letter: 2016-10-26
• Label: 2016-10-31
• Letter: 2017-10-19
• Label: 2017-10-25
• Letter: 2018-04-16
• Label: 2018-04-17
• Medication Guide: 2018-06-11
• Label: 2018-06-11
• Label: 2018-06-11
• Letter: 2018-06-14
• Letter: 2018-06-14
• Letter: 2020-09-14
• Label: 2020-09-17
• Letter: 2020-11-30
• Label: 2020-11-30
• Medication Guide: 2020-11-30
• Letter: 2022-03-07
• Label: 2022-03-10
• Medication Guide: 2022-03-10

Application Sponsors

NDA 021428

TAKEDA PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	15MG	1	PREVACID	LANSOPRAZOLE
002	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	30MG	1	PREVACID	LANSOPRAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-08-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2004-06-15	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2004-06-17	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2006-04-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2007-06-14	STANDARD
LABELING; Labeling	SUPPL	13	AP	2008-04-21	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2008-10-28	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2009-07-31	STANDARD
LABELING; Labeling	SUPPL	20	AP	2010-05-12	UNKNOWN
LABELING; Labeling	SUPPL	21	AP	2010-09-03	UNKNOWN
LABELING; Labeling	SUPPL	22	AP	2011-06-01	STANDARD
LABELING; Labeling	SUPPL	23	AP	2011-10-28	UNKNOWN
LABELING; Labeling	SUPPL	24	AP	2011-05-20	901 REQUIRED
LABELING; Labeling	SUPPL	25	AP	2012-09-28	STANDARD
LABELING; Labeling	SUPPL	26	AP	2012-05-03	STANDARD
LABELING; Labeling	SUPPL	27	AP	2015-12-16	STANDARD
LABELING; Labeling	SUPPL	28	AP	2014-12-19	901 REQUIRED
LABELING; Labeling	SUPPL	30	AP	2016-10-24	STANDARD
LABELING; Labeling	SUPPL	31	AP	2017-10-18	STANDARD
LABELING; Labeling	SUPPL	32	AP	2018-04-13	STANDARD
LABELING; Labeling	SUPPL	34	AP	2018-06-07	STANDARD
LABELING; Labeling	SUPPL	35	AP	2018-06-07	STANDARD
LABELING; Labeling	SUPPL	37	AP	2020-09-11	STANDARD
LABELING; Labeling	SUPPL	39	AP	2020-11-27	STANDARD
LABELING; Labeling	SUPPL	41	AP	2022-03-04	STANDARD

Submissions Property Types

SUPPL	17	Null	8
SUPPL	19	Null	7
SUPPL	20	Null	31
SUPPL	21	Null	6
SUPPL	22	Null	6
SUPPL	23	Null	6
SUPPL	24	Null	6
SUPPL	25	Null	6
SUPPL	26	Null	6
SUPPL	27	Null	6
SUPPL	28	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	7
SUPPL	32	Null	15
SUPPL	34	Null	15
SUPPL	35	Null	15
SUPPL	37	Null	15
SUPPL	39	Null	7
SUPPL	41	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TAKEDA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21428
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/020406s092,021428s039lbl.pdf#page=44"]
            [products] => [{"drugName":"PREVACID","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PREVACID","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/27\/2020","submission":"SUPPL-39","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020406s092,021428s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2020","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020406s092,021428s039lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2020","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020406s090,021428s037lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2018","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021428s028lbl020406s081lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021428s028lbl020406s081lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020406s078-021428s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2012","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020406s079,021428s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2011","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020406s076,021428s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2011","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020406s075,021428s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2011","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020406s077,021428s024lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2010","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020406s074,021428s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2010","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020406s073,021428s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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            [supplements] => 
            [actionDate] => 2020-11-27
        )

)