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Back to FDA Applications sponsored by BAYER HEALTHCARE LLC
FDA Drug Application 020470 by BAYER HEALTHCARE LLC
Application Number
020470
Application Type
New Drug Application
Sponsor Applicant
BAYER HEALTHCARE LLC
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
8/23/1996
N
AP
0
3/26/1997
SLR
AP
0
10/6/1997
SLR
AP
0
1/23/1998
SCM
15930
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml
3/2/2007
AP
0
5/4/1998
SCS
AP
0
12/4/1998
SCS
818
005
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20470-S005_Claritin.pdf
12/4/1998
AP
0
10/29/1998
SCM
15936
007
http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml
3/2/2007
AP
0
10/1/1999
SCS
AP
0
9/13/2000
SCS
15940
010
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml
3/2/2007
AP
0
2/14/2000
SCS
AP
0
9/13/2000
SCS
AP
0
1/30/2002
SCS
AP
0
11/27/2002
SE6
2482
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19670se6-018,20470se6-016ltr.pdf
11/27/2002
AP
0
11/27/2002
SE6
10747
016
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm
12/7/2004
AP
0
12/9/2002
SCE
AP
0
6/25/2003
SLR
6051
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20470slr019ltr.pdf
7/6/2003
AP
0
7/30/2004
SE1
9925
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr.pdf
8/2/2004
AP
0
7/30/2004
SE1
9932
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf
8/2/2004
AP
0
7/15/2004
SLR
9776
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20470s023ltr.pdf
7/21/2004
AP
0
1/25/2010
SLR
24801
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034ltr.pdf
2/17/2010
AP
0
2/13/2013
SCM
AP
0
4/26/2013
SCM
AP
0
1/3/2014
SCM
AP
0
11/25/2015
SLR
44617
044
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470Orig1s044ltr.pdf
11/27/2015
AP
0
11/25/2015
SLR
44750
044
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf
12/11/2015
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