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Back to FDA Applications sponsored by DENTSPLY PHARM
FDA Drug Application 021451 by DENTSPLY PHARM
Application Number
021451
Application Type
New Drug Application
Sponsor Applicant
DENTSPLY PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New combination
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
12/19/2003
N
7348
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21451ltr.pdf
12/23/2003
AP
0
12/19/2003
N
7439
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21451_oraqix_lbl.pdf
12/29/2003
AP
0
12/19/2003
N
14796
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021451s000_OraqixTOC.cfm
9/7/2006
AP
0
4/13/2010
SLR
25289
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s005lbl.pdf
4/19/2010
AP
0
4/13/2010
SLR
25307
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021451s005ltr.pdf
4/20/2010
AP
0
9/27/2010
SLR
26554
007
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s007lbl.pdf
9/27/2010
AP
0
9/27/2010
SLR
26557
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021451s007ltr.pdf
9/29/2010
AP
0
8/8/2012
SLR
33419
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021451s008lbl.pdf
8/9/2012
AP
0
8/8/2012
SLR
33421
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021451Orig1s008ltr.pdf
8/10/2012
Back to FDA Applications sponsored by DENTSPLY PHARM