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Back to FDA Applications sponsored by TAKEDA PHARMS NA
FDA Drug Application 021281 by TAKEDA PHARMS NA
Application Number
021281
Application Type
New Drug Application
Sponsor Applicant
TAKEDA PHARMS NA
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
Therapeutic Potential
Standard
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
5/3/2001
N
3877
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21281_Prevacid_Aprov.pdf
5/3/2001
AP
0
5/3/2001
N
3878
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21281lbl.pdf
5/3/2001
AP
0
5/3/2001
N
3879
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21281_Prevacid.cfm
5/3/2001
AP
0
5/3/2001
N
31069
000
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm
12/20/2011
AP
0
12/7/2001
SCS
AP
0
5/3/2002
SLR
3875
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406s045and21281s002ltr.pdf
5/3/2002
AP
0
5/3/2002
SLR
3876
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf
5/3/2002
AP
0
3/7/2002
SCS
AP
0
12/3/2002
SLR
3874
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406slr048,21281slr004ltr.pdf
12/3/2002
AP
0
12/3/2002
SLR
18503
004
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021281_S004_PREVACID.pdf
11/19/2007
AP
0
12/3/2002
SCE
AP
0
8/30/2002
SLR
3698
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf
8/30/2002
AP
0
8/30/2002
SLR
3699
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf
8/30/2002
AP
0
8/30/2002
SLR
11857
007
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm
6/23/2005
AP
0
8/5/2003
SLR
6519
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf
8/15/2003
AP
0
6/15/2004
SLR
AP
0
6/17/2004
SE8
9490
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf
12/21/2004
AP
0
6/17/2004
SE8
9497
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf
6/23/2004
AP
0
6/17/2004
SE8
20358
014
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021281_s014_PREVACID DELAYED REL CAPS.pdf
7/31/2008
AP
0
4/12/2006
SLR
13925
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf
4/13/2006
AP
0
4/12/2006
SLR
13931
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf
4/13/2006
AP
0
6/14/2007
SLR
16827
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf
6/27/2007
AP
0
6/14/2007
SLR
16924
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf
7/5/2007
AP
0
4/21/2008
SLR
19703
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf
4/23/2008
AP
0
10/28/2008
SLR
21103
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf
10/29/2008
AP
0
10/28/2008
SLR
21156
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf
11/7/2008
AP
0
7/31/2009
S
23172
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf
8/13/2009
AP
0
7/31/2009
S
23834
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf
11/12/2009
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