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Back to FDA Applications sponsored by PHARMACIA AND UPJOHN
FDA Drug Application 050639 by PHARMACIA AND UPJOHN
Application Number
050639
Application Type
New Drug Application
Sponsor Applicant
PHARMACIA AND UPJOHN
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
8/30/1989
N
AP
0
4/18/1991
SCG
AP
0
6/11/1991
SLR
AP
0
4/10/1991
SCG
AP
0
5/21/1992
SCS
AP
0
3/17/1997
SLR
AP
0
12/20/1995
SLR
AP
0
4/5/1993
SCS
AP
0
2/21/1995
SLR
AP
0
3/9/1998
SCM
AP
0
7/17/1997
SLR
AP
0
12/12/1997
SLR
AP
0
9/29/2004
SLR
10361
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf
10/4/2004
AP
0
9/29/2004
SLR
10362
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf
10/4/2004
AP
0
1/28/2004
SLR
7634
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf
2/2/2004
AP
0
2/21/2008
SLR
19278
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf
2/25/2008
AP
0
2/21/2008
SLR
19290
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050639s015ltr.pdf
2/25/2008
AP
0
4/14/2008
SLR
19654
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s055,050639s016ltr.pdf
4/16/2008
AP
0
4/14/2008
SLR
19716
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf
4/23/2008
AP
0
6/7/2011
SLR
29090
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf
6/10/2011
AP
0
6/26/2013
SCM
AP
0
10/9/2013
SCM
AP
0
6/25/2014
SLR
39673
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf
6/27/2014
AP
0
6/25/2014
SLR
39751
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf
7/3/2014
AP
0
6/25/2014
SLR
39674
028
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf
6/27/2014
AP
0
6/25/2014
SLR
39752
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf
7/3/2014
AP
0
6/25/2014
SLR
39675
029
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf
6/27/2014
AP
0
6/25/2014
SLR
39753
029
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf
7/3/2014
AP
0
9/18/2014
SCM
AP
0
3/24/2016
SLR
45516
031
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s071,050639Orig1s031ltr.pdf
3/28/2016
AP
0
3/24/2016
SLR
45524
031
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf
3/29/2016
AP
0
5/20/2016
SCM
AP
0
8/5/2016
SLR
46740
033
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s072,050639Orig1s033ltr.pdf
8/9/2016
AP
0
8/5/2016
SLR
46753
033
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf
8/9/2016
AP
0
8/5/2016
SLR
46741
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf
8/9/2016
AP
0
8/5/2016
SLR
46754
034
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s073,050639s034lbl.pdf
8/9/2016
Back to FDA Applications sponsored by PHARMACIA AND UPJOHN