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Back to FDA Applications sponsored by HOSPIRA INC
FDA Drug Application 050679 by HOSPIRA INC
Application Number
050679
Application Type
New Drug Application
Sponsor Applicant
HOSPIRA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
1/18/1996
N
18664
000
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm198675.htm
12/17/2007
AP
0
3/13/1996
SCS
AP
0
5/16/1997
SE1
4305
002
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050679s002.cfm
5/16/1997
AP
0
12/23/1996
SCS
AP
0
10/20/1997
SCM
AP
0
2/8/1999
SLR
AP
0
1/27/1999
SLR
3530
007
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine.cfm
7/18/2001
AP
0
1/27/1999
SLR
4804
007
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_Approv.pdf
1/27/1999
AP
0
1/27/1999
SLR
4805
007
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50679S007_Maxipine_prntlbl.pdf
1/27/1999
AP
0
1/30/1998
SE1
AP
0
8/21/2002
SLR
3528
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf
8/21/2002
AP
0
1/30/1998
SCP
AP
0
7/21/1998
SCS
AP
0
11/24/1998
SCM
AP
0
9/20/2000
SLR
AP
0
8/21/2002
SLR
3527
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf
8/21/2002
AP
0
6/26/2000
SLR
AP
0
5/10/2000
SCM
AP
0
4/2/2001
SCP
AP
0
8/21/2002
SLR
3529
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50679slr009,014,018ltr.pdf
8/21/2002
AP
0
6/20/2001
SCP
AP
0
3/15/2002
SCS
AP
0
3/17/2003
SE2
4493
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50679se2-021_maxipime_lbl.pdf
3/26/2003
AP
0
3/17/2003
SE2
4494
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50679se2-021ltr.pdf
3/26/2003
AP
0
6/9/2004
S
9305
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50679slr023ltr.pdf
6/10/2004
AP
0
6/9/2004
S
9320
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50679slr023_maxipime_lbl.pdf
6/10/2004
AP
0
9/14/2007
SLR
18581
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050679s024ltr_CKD.pdf
11/26/2007
AP
0
9/14/2007
SLR
17901
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050679s028lbl.pdf
9/19/2007
AP
0
5/1/2014
SLR
39198
031
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050679s031lbl.pdf
5/2/2014
AP
0
5/1/2014
SLR
39222
031
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050679Orig1s031ltr.pdf
5/6/2014
AP
0
9/30/2009
SLR
23476
032
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050679s032lbl.pdf
9/30/2009
AP
0
9/30/2009
SLR
24056
032
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050679s032ltr.pdf
11/20/2009
AP
0
3/15/2013
SLR
35473
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050679Orig1s034ltr.pdf
3/18/2013
AP
0
3/15/2013
SLR
35480
034
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050679s034lbl.pdf
3/19/2013
AP
0
9/6/2012
SLR
33685
036
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050679Orig1s036ltr.pdf
9/10/2012
AP
0
9/6/2012
SLR
33714
036
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050679s036lbl.pdf
9/11/2012
AP
0
6/12/2014
SCM
AP
0
3/4/2016
SCM
AP
0
3/1/2016
SLR
45335
040
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050679Orig1s040ltr.pdf
3/3/2016
AP
0
3/1/2016
SLR
45346
040
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050679s040lbl.pdf
3/3/2016
AP
0
6/22/2016
SCM
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