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Back to FDA Applications sponsored by GE HEALTHCARE
FDA Drug Application 020372 by GE HEALTHCARE
Application Number
020372
Application Type
New Drug Application
Sponsor Applicant
GE HEALTHCARE
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
2/9/1996
N
AP
0
12/7/1998
SCM
AP
0
12/9/1998
SCM
AP
0
11/23/2001
SE1
3660
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_Approv.pdf
11/3/2001
AP
0
11/23/2001
SE1
3661
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview_prntlbl.pdf
11/3/2001
AP
0
11/23/2001
SE1
3662
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20372_Myoview.cfm
3/12/2002
AP
0
11/12/1999
SCS
AP
0
4/13/2000
SCE
AP
0
4/12/2000
SCM
AP
0
9/29/2000
SCM
AP
0
4/10/2001
SCM
AP
0
8/27/2001
SCM
5408
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20372s9lbl.pdf
4/22/2003
AP
0
12/4/2001
SCM
AP
0
5/22/2002
SCM
3659
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20372scm011ltr.pdf
5/22/2002
AP
0
11/25/2002
SCS
AP
0
2/28/2003
SE1
4075
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020372s013lbl.pdf
3/5/2003
AP
0
2/28/2003
SE1
4242
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372se1-013ltr.pdf
3/10/2003
AP
0
2/28/2003
SE1
6105
013
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-372s013_Myoview.cfm
7/8/2003
AP
0
11/13/2003
SLR
6985
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20372slr015ltr.pdf
11/26/2003
AP
0
11/13/2003
SLR
7001
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20372slr015_myoview_lbl.pdf
12/1/2003
AP
0
7/7/2005
SCF
11988
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020372s019lbl.pdf
7/15/2005
AP
0
7/7/2005
SCF
11996
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020372s019ltr.pdf
7/15/2005
AP
0
2/26/2009
SCF
21958
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020372s022ltr.pdf
3/5/2009
AP
0
2/26/2009
SCF
22038
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020372s022lbl.pdf
3/17/2009
AP
0
3/8/2013
SCM
Back to FDA Applications sponsored by GE HEALTHCARE