FDA.reportPublic FDA data

Application 020406

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREVACIDLANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL15MGYesNo
002PREVACIDLANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL30MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-474LansoprazolelansoprazoleRebel Distributors CorpNDACurrent
21695-652LansoprazolelansoprazoleRebel Distributors CorpNDACurrent
49999-480PrevacidlansoprazoleLake Erie Medical DBA Quality Care Products LLCNDACurrent
55289-704PrevacidlansoprazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-704PrevacidlansoprazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-704PrevacidlansoprazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-704PrevacidlansoprazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-704PrevacidlansoprazolePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-704PrevacidlansoprazolePD-Rx Pharmaceuticals, Inc.NDACurrent
63629-3352PrevacidlansoprazoleBryant Ranch PrepackNDACurrent
64764-046PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-046PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-046PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-046PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-046PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-046PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-046PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-541PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-541PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-541PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-541PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-541PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-541PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
64764-541PrevacidlansoprazoleTakeda Pharmaceuticals America, Inc.NDACurrent
70518-0502PrevacidlansoprazoleREMEDYREPACK INC.NDACurrent
70518-0502PrevacidlansoprazoleREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75041SUPPL 2023-08-10
75040SUPPL 2023-08-10
75022SUPPL 2023-08-09
70478SUPPL2022-03-10
70463SUPPL2022-03-10
70409SUPPL2022-03-07
65413SUPPL2020-11-30
65412SUPPL2020-11-30
65374SUPPL2020-11-30
64586SUPPL2020-09-17
64567SUPPL2020-09-14
54575SUPPL2018-06-14
54574SUPPL2018-06-14
54514SUPPL2018-06-11
54513SUPPL2018-06-11
54512SUPPL2018-06-11
54511SUPPL2018-06-11
53707SUPPL2018-04-17
53696SUPPL2018-04-16
50182SUPPL2017-10-25
50100SUPPL2017-10-19
45714SUPPL2016-10-31
45664SUPPL2016-10-26
24930SUPPL2015-12-18
34620SUPPL2015-12-17
34621SUPPL2014-12-29
24931SUPPL2014-12-24
2497SUPPL2012-10-02
12550SUPPL2012-10-01
24929SUPPL2012-05-09
34619SUPPL2012-05-07
23580ORIG2011-12-20
41344SUPPL2011-12-09
12549SUPPL2011-11-01
24927SUPPL2011-10-31
34617SUPPL2011-06-07
2496SUPPL2011-06-03
34618SUPPL2011-05-26
24928SUPPL2011-05-25
12548SUPPL2010-09-10
2495SUPPL2010-09-09
34616SUPPL2010-05-17
2494SUPPL2010-05-17
41339ORIG2010-03-16
2493SUPPL2009-11-12
41351SUPPL2009-09-16
41350SUPPL2009-09-16
41346SUPPL2009-09-16
41345SUPPL2009-09-16
41342SUPPL2009-09-16
41341SUPPL2009-09-16
41340SUPPL2009-09-16
20648SUPPL2009-09-16
20647SUPPL2009-09-16
20646SUPPL2009-09-16
20644SUPPL2009-09-16
20643SUPPL2009-09-16
20642SUPPL2009-09-16
20639SUPPL2009-09-16
20638SUPPL2009-09-16
20637SUPPL2009-09-16
20636SUPPL2009-09-16
34615SUPPL2009-08-13
12547SUPPL2008-11-07
2492SUPPL2008-10-29
52963SUPPL2008-07-15
52962SUPPL2008-07-15
52961SUPPL2008-07-15
52960SUPPL2008-07-15
52305SUPPL2008-07-15
52304SUPPL2008-07-15
52303SUPPL2008-07-15
52302SUPPL2008-07-15
2491SUPPL2008-04-23
20649SUPPL2007-11-19
24926SUPPL2007-07-05
12546SUPPL2007-06-27
34614SUPPL2006-04-13
24925SUPPL2006-04-13
41352SUPPL2005-06-23
12545SUPPL2004-12-21
2490SUPPL2004-06-23
34613SUPPL2004-06-16
2489SUPPL2004-06-16
24924SUPPL2003-08-15
24920SUPPL2003-07-31
34611SUPPL2003-04-24
24923SUPPL2002-12-03
12544SUPPL2002-08-30
2488SUPPL2002-08-30
24922SUPPL2002-07-31
12543SUPPL2002-07-31
34612SUPPL2002-05-03
24921SUPPL2002-05-03
34610SUPPL2000-11-30
24919SUPPL2000-11-30
20645SUPPL2000-06-20
41348SUPPL1999-07-06
24918SUPPL1999-07-06
41349SUPPL1999-02-22