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Back to FDA Applications sponsored by SHIRE
FDA Drug Application 021303 by SHIRE
Application Number
021303
Application Type
New Drug Application
Sponsor Applicant
SHIRE
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
10/11/2001
N
2633
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall_Approv.pdf
10/11/2001
AP
0
10/11/2001
N
2634
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21303lbl.pdf
10/11/2001
AP
0
10/11/2001
N
8582
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall.cfm
5/25/2004
AP
0
10/11/2001
N
11409
000
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111441.htm
4/15/2005
AP
0
10/11/2001
N
24213
000
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085819.pdf
12/4/2009
AP
0
5/22/2002
SCM
2631
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21303s001ltr.pdf
5/22/2002
AP
0
5/22/2002
SCM
2632
001
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21303s1lbl.pdf
5/22/2002
AP
0
5/22/2002
SCM
16824
001
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021303_S001_AdderallTOC.cfm
6/22/2007
AP
0
9/13/2002
SCS
AP
0
8/11/2004
SE5
10004
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21303s005ltr.pdf
8/12/2004
AP
0
8/11/2004
SE5
11086
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021303s005lbl.pdf
2/7/2005
AP
0
7/21/2005
SE5
12271
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021303s009ltr.pdf
7/26/2005
AP
0
7/21/2005
SE5
12285
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021303s009lbl.pdf
7/26/2005
AP
0
6/16/2006
SLR
14324
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021303s010lbl.pdf
6/20/2006
AP
0
6/16/2006
SLR
14332
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021303s010LTR.pdf
6/20/2006
AP
0
7/26/2006
SLR
14538
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf
7/27/2006
AP
0
7/26/2006
SLR
14550
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf
7/27/2006
AP
0
5/22/2007
SLR
16598
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021303s015ltr.pdf
5/29/2007
AP
0
5/22/2007
SLR
16643
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021303s015lbl.pdf
5/29/2007
AP
0
11/12/2008
SLR
21224
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021303s019,021977s008ltr.pdf
11/13/2008
AP
0
11/12/2010
SLR
26961
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf
11/17/2010
AP
0
11/12/2010
SLR
26962
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022MedGuide.pdf
11/17/2010
AP
0
11/12/2010
SLR
26976
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf
11/18/2010
AP
0
11/12/2010
SLR
26959
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022MedGuide.pdf
11/17/2010
AP
0
11/12/2010
SLR
26960
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf
11/17/2010
AP
0
11/12/2010
SLR
26977
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf
11/18/2010
AP
0
2/7/2012
SLR
31723
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021303s023mg.pdf
2/9/2012
AP
0
2/7/2012
SLR
31724
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021303s023lbl.pdf
2/9/2012
AP
0
2/7/2012
SLR
31735
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021303s023ltr.pdf
2/10/2012
AP
0
6/14/2013
SLR
36299
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s024lbl.pdf
6/18/2013
AP
0
6/14/2013
SLR
36329
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s024ltr.pdf
6/18/2013
AP
0
3/8/2013
SLR
35396
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s025ltr.pdf
3/11/2013
AP
0
3/8/2013
SLR
35430
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s025lbl.pdf
3/12/2013
AP
0
12/3/2013
SLR
37962
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s026lbl.pdf
12/4/2013
AP
0
12/3/2013
SLR
37975
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s026ltr.pdf
12/5/2013
AP
0
7/24/2014
SLR
40003
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021303Orig1s027ltr.pdf
7/25/2014
AP
0
7/24/2014
SLR
40011
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021303s027lbl.pdf
7/28/2014
AP
0
3/3/2015
SCM
AP
0
4/17/2015
SLR
42586
031
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021303Orig1s031ltr.pdf
4/21/2015
AP
0
4/17/2015
SLR
42602
031
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021303s031lbl.pdf
4/21/2015
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