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Back to FDA Applications sponsored by AQUA PHARMS
FDA Drug Application 021946 by AQUA PHARMS
Application Number
021946
Application Type
New Drug Application
Sponsor Applicant
AQUA PHARMS
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
7/28/2006
N
14596
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021946lbl.pdf
8/4/2006
AP
0
7/28/2006
N
14604
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021946s000LTR.pdf
8/4/2006
AP
0
7/28/2006
N
20737
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021946s000TOC.cfm
9/4/2008
AP
0
12/19/2008
SCP
21506
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021946s002lbl.pdf
1/6/2009
AP
0
12/30/2009
SLR
24409
003
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021946s003lbl.pdf
1/4/2010
AP
0
12/30/2009
SLR
24433
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021946s003ltr.pdf
1/5/2010
AP
0
12/6/2010
SLR
27241
004
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021946s004lbl.pdf
12/6/2010
AP
0
12/6/2010
SLR
27267
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021946s004ltr.pdf
12/10/2010
AP
0
5/10/2012
SLR
32684
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021946s005ltr.pdf
5/14/2012
AP
0
5/10/2012
SLR
32699
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021946s005lbl.pdf
5/16/2012
AP
0
2/27/2013
SCM
Back to FDA Applications sponsored by AQUA PHARMS