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Back to FDA Applications sponsored by PFIZER
FDA Drug Application 011641 by PFIZER
Application Number
011641
Application Type
New Drug Application
Sponsor Applicant
PFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
Therapeutic Potential
Priority
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
10/28/1958
N
AP
0
5/16/1978
SCP
AP
0
2/24/1978
SLR
AP
0
3/3/1981
SCP
AP
0
5/28/1982
SCS
AP
0
10/18/1984
SPD
AP
0
9/4/1984
SCP
AP
0
9/4/1984
SCP
AP
0
9/4/1984
SCS
AP
0
2/24/1987
SCP
AP
0
5/12/1987
SLR
AP
0
1/28/1993
SCS
AP
0
11/24/1993
SCM
AP
0
5/16/2002
SLR
1675
058
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11641s058ltr.pdf
5/16/2002
AP
0
5/16/2002
SLR
15259
058
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011641_058&060_Diabinese_APPROVAL_PACKAGE.pdf
10/26/2006
AP
0
12/15/1999
SCP
AP
0
5/16/2002
SLR
1676
060
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11641s058ltr.pdf
5/16/2002
AP
0
5/16/2002
SLR
15260
060
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011641_058&060_Diabinese_APPROVAL_PACKAGE.pdf
10/26/2006
AP
0
1/4/2004
SLR
7490
061
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11641slr061ltr.pdf
1/9/2004
AP
0
1/4/2004
SLR
17052
061
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/011641_S061_DIABINESE_TABLETS_AP.pdf
7/6/2007
AP
0
10/27/2008
SCA
21095
064
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011641s064ltr.pdf
10/29/2008
AP
0
10/27/2008
SCA
21143
064
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011641s064lbl.pdf
11/7/2008
AP
0
8/27/2009
SLR
23368
065
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011641s065lbl.pdf
9/17/2009
AP
0
8/27/2009
SLR
30816
065
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/011641Orig1s065.pdf
10/10/2011
AP
0
2/1/2011
SLR
27705
066
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011641s066ltr.pdf
2/4/2011
AP
0
2/1/2011
SLR
27727
066
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011641s066lbl.pdf
2/4/2011
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