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Back to FDA Applications sponsored by BRACCO
FDA Drug Application 019414 by BRACCO
Application Number
019414
Application Type
New Drug Application
Sponsor Applicant
BRACCO
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
12/29/1989
N
31384
000
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm287453.htm
1/12/2012
AP
0
3/6/1990
SCM
AP
0
11/14/1991
SCM
AP
0
11/21/1997
SCM
AP
0
5/29/1998
SCM
AP
0
3/23/1999
SCM
AP
0
4/5/2001
SCM
4939
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19414S6ltr.pdf
4/11/2001
AP
0
7/21/2009
SLR
23029
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019414s011ltr.pdf
7/23/2009
AP
0
7/21/2009
SLR
23063
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf
7/23/2009
AP
0
7/28/2010
SE8
26043
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019414s012ltr.pdf
7/30/2010
AP
0
7/28/2010
SE8
26075
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf
7/31/2010
AP
0
2/8/2012
SLR
31725
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf
2/9/2012
AP
0
2/8/2012
SLR
31738
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019414s014ltr.pdf
2/10/2012
AP
0
4/22/2013
SCM
AP
0
12/5/2014
SCM
Back to FDA Applications sponsored by BRACCO