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Back to FDA Applications sponsored by US PHARM HOLDINGS
FDA Drug Application 050596 by US PHARM HOLDINGS
Application Number
050596
Application Type
New Drug Application
Sponsor Applicant
US PHARM HOLDINGS
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
5/20/1985
N
AP
0
6/13/1985
SLR
AP
0
9/23/1985
SLR
AP
0
7/23/1985
SLR
AP
0
3/5/1992
SCF
AP
0
8/7/1989
SCS
AP
0
8/10/1992
SCS
AP
0
9/24/1996
SLR
AP
0
5/19/1994
SCM
AP
0
11/22/1994
SLR
AP
0
6/16/1994
SCM
AP
0
9/14/1994
SLR
AP
0
9/2/1994
SLR
AP
0
4/30/1996
SLR
AP
0
12/23/1996
SLR
AP
0
4/24/1997
SLR
AP
0
1/18/2002
SLR
2468
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf
1/18/2002
AP
0
2/18/2000
SCM
AP
0
4/10/2001
SCS
AP
0
4/12/2001
SCM
AP
0
7/27/2001
SCM
AP
0
9/6/2001
SCS
AP
0
6/23/2004
SLR
9525
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf
6/24/2004
AP
0
9/2/2004
SLR
AP
0
2/21/2008
SLR
19283
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf
2/25/2008
AP
0
2/21/2008
SLR
19289
035
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050596s035ltr.pdf
2/25/2008
AP
0
5/27/2009
SLR
22670
036
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf
6/2/2009
AP
0
9/9/2011
SLR
29986
037
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf
9/13/2011
AP
0
9/9/2011
SLR
30024
037
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf
9/16/2011
AP
0
5/3/2013
SCM
AP
0
2/21/2014
SLR
38571
040
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf
2/25/2014
AP
0
2/21/2014
SLR
38582
040
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf
2/25/2014
AP
0
4/21/2014
SCM
AP
0
3/23/2015
SLR
42246
042
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf
3/24/2015
AP
0
3/23/2015
SLR
42527
042
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf
4/14/2015
Back to FDA Applications sponsored by US PHARM HOLDINGS