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Back to FDA Applications sponsored by MERCK SHARP DOHME
FDA Drug Application 018827 by MERCK SHARP DOHME
Application Number
018827
Application Type
New Drug Application
Sponsor Applicant
MERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New combination
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
7/10/1984
N
AP
0
2/22/1985
SCP
AP
0
4/23/1986
SCM
AP
0
5/20/1986
SCS
AP
0
9/12/1986
SCM
AP
0
10/29/1987
SCM
AP
0
8/1/1990
SCS
AP
0
10/3/2001
SLR
5255
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf
4/15/2003
AP
0
9/11/1990
SCS
AP
0
10/3/2001
SLR
AP
0
10/6/1994
SCP
AP
0
1/30/1995
SCM
AP
0
1/30/1995
SCS
AP
0
6/15/1998
SCS
AP
0
7/31/1998
SCS
AP
0
5/18/1998
SCS
AP
0
11/10/1998
SCP
AP
0
5/14/1999
SCS
AP
0
2/2/2000
SCS
AP
0
10/3/2001
SLR
AP
0
2/28/2001
SCS
AP
0
10/3/2001
SE5
6278
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18827s22ltr.pdf
7/31/2003
AP
0
10/3/2001
SE5
12391
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf
7/29/2005
AP
0
1/10/2002
SCS
AP
0
3/27/2003
SLR
4646
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf
3/28/2003
AP
0
3/27/2003
SLR
5275
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18827slr025ltr.pdf
4/15/2003
AP
0
1/25/2008
SLR
18963
038
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018827s038ltr.pdf
1/29/2008
AP
0
1/25/2008
SLR
18969
038
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf
1/30/2008
AP
0
5/11/2009
SLR
22567
042
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018827s042ltr.pdf
5/13/2009
AP
0
5/11/2009
SLR
22890
042
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf
7/8/2009
AP
0
4/21/2014
SLR
39111
046
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018827Orig1s046ltr.pdf
4/22/2014
AP
0
4/21/2014
SLR
39118
046
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf
4/22/2014
Back to FDA Applications sponsored by MERCK SHARP DOHME