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Back to FDA Applications sponsored by PFIZER
FDA Drug Application 019152 by PFIZER
Application Number
019152
Application Type
New Drug Application
Sponsor Applicant
PFIZER
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
12/16/1986
N
AP
0
9/24/1987
SCP
AP
0
11/30/1988
SCM
AP
0
11/30/1988
SCM
AP
0
11/30/1988
SCM
AP
0
7/20/1988
SLR
AP
0
3/6/1991
SCM
AP
0
8/8/1989
SCP
AP
0
9/22/1988
SLR
AP
0
12/15/1989
SE2
AP
0
6/14/1989
SCP
AP
0
3/30/1989
SCM
AP
0
5/17/1989
SCP
AP
0
1/19/1990
SCM
AP
0
3/6/1991
SCF
AP
0
7/28/1994
SCM
AP
0
5/4/1992
SCE
AP
0
9/3/1992
SLR
AP
0
9/23/1992
SCE
AP
0
3/17/1995
SCM
AP
0
11/5/1993
SCP
AP
0
1/13/1998
SLR
AP
0
5/16/1997
SCM
AP
0
12/11/1998
SCM
AP
0
9/28/2001
SLR
AP
0
7/14/2000
SCM
AP
0
2/12/2001
SCE
AP
0
2/14/2001
SCS
AP
0
11/26/2002
SCS
1925
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19152scs030ltr.pdf
11/26/2002
AP
0
7/1/2009
SLR
22894
032
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019152s032ltr.pdf
7/8/2009
AP
0
7/1/2009
SLR
22931
032
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf
7/9/2009
AP
0
3/31/2010
SLR
25183
033
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019152s033ltr.pdf
4/2/2010
AP
0
3/31/2010
SLR
25194
033
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf
4/4/2010
AP
0
12/1/2011
SLR
30865
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf
12/2/2011
AP
0
12/1/2011
SLR
30878
035
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019152s035ltr.pdf
12/5/2011
AP
0
1/10/2013
SCM
AP
0
10/28/2013
SLR
37598
038
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019152Orig1s038ltr.pdf
10/28/2013
AP
0
10/28/2013
SLR
37599
038
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf
10/28/2013
AP
0
8/24/2016
SLR
46884
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019152Orig1s039ltr.pdf
8/25/2016
AP
0
8/24/2016
SLR
46978
039
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019152s039lbl.pdf
9/6/2016
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