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Back to FDA Applications sponsored by MERCK
FDA Drug Application 050630 by MERCK
Application Number
050630
Application Type
New Drug Application
Sponsor Applicant
MERCK
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
12/14/1990
N
AP
0
8/26/1991
SCS
AP
0
11/4/1993
SLR
AP
0
11/4/1993
SLR
AP
0
11/23/1992
SLR
AP
0
11/23/1992
SLR
AP
0
6/24/1994
SLR
AP
0
10/2/1996
SLR
20567
009
http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050630_S009_PRIMAXIN.pdf
8/11/2008
AP
0
9/27/1994
SCM
AP
0
1/9/1997
SLR
20557
011
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050630_S011_PRIMAXIN.pdf
8/11/2008
AP
0
4/27/1995
SCS
AP
0
6/30/1997
SLR
20556
014
http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050630_S014_PRIMAXIN.pdf
8/11/2008
AP
0
2/4/1999
SLR
3900
015
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50638S15_Primaxin.pdf
2/4/1999
AP
0
4/10/2000
SCS
AP
0
11/30/2001
SLR
3899
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf
11/30/2001
AP
0
8/29/2001
SCS
AP
0
5/28/2002
SCM
19144
019
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050630_S019_PRIMAXIN.pdf
2/19/2008
AP
0
3/4/2003
SLR
4236
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50587SLR058,50630SLR021ltr.pdf
3/10/2003
AP
0
3/4/2003
SLR
19140
021
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050630_S021_PRIMAXIN.pdf
2/19/2008
AP
0
5/20/2004
SLR
8628
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr061ltr.pdf
5/26/2004
AP
0
5/20/2004
SLR
19145
023
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050630_S023_PRIMAXIN.pdf
2/19/2008
AP
0
8/4/2006
SLR
14628
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050587s064, 050630s026LTR.pdf
8/7/2006
AP
0
3/22/2007
SLR
16119
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050630s027LTR.pdf
3/31/2007
AP
0
3/22/2007
SLR
16135
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050630s027lbl.pdf
3/31/2007
AP
0
3/28/2008
SLR
19558
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf
4/1/2008
AP
0
3/28/2008
SLR
19569
028
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s065, 050630s028ltr.pdf
4/2/2008
AP
0
5/8/2008
SLR
21366
033
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s070, 050630s033ltr.pdf
12/19/2008
AP
0
8/26/2009
SLR
23440
035
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf
9/22/2009
AP
0
8/26/2009
SLR
24136
035
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050587s072,050630s035ltr.pdf
11/25/2009
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