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Back to FDA Applications sponsored by PFIZER
FDA Drug Application 011459 by PFIZER
Application Number
011459
Application Type
New Drug Application
Sponsor Applicant
PFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New ester, new salt, or other noncovalent derivative
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
11/15/1968
N
AP
0
12/2/1974
SCS
AP
0
5/21/1979
SLR
AP
0
11/28/1994
SCM
AP
0
8/30/2000
SLR
AP
0
3/21/2001
SLR
4561
036
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11795S18LTR.PDF
3/21/2001
AP
0
3/27/2000
SCP
AP
0
6/13/2000
SCM
AP
0
12/24/2004
SLR
10812
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11459s039,11795s020ltr.pdf
12/29/2004
AP
0
6/3/2014
SLR
39443
048
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011459s048,011795s025lbl.pdf
6/4/2014
AP
0
6/3/2014
SLR
39451
048
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011459Orig1s048,011795Orig1s025ltr.pdf
6/5/2014
AP
0
2/18/2016
SLR
45221
050
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011459Orig1s050,011795Orig1s027ltr.pdf
2/22/2016
AP
0
2/18/2016
SLR
45408
050
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011459s050,011795s027lbl.pdf
3/10/2016
Back to FDA Applications sponsored by PFIZER