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Back to FDA Applications sponsored by MYLAN SPECLT
FDA Drug Application 019430 by MYLAN SPECLT
Application Number
019430
Application Type
New Drug Application
Sponsor Applicant
MYLAN SPECLT
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New manufacturer
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
12/22/1987
N
AP
0
3/2/1989
SLR
AP
0
8/3/1995
SCS
AP
0
7/25/1996
SCS
AP
0
1/24/1997
SCM
AP
0
5/25/1999
SCM
AP
0
12/15/1999
SCM
AP
0
11/5/1999
SCM
AP
0
5/11/2000
SCM
AP
0
1/11/2001
SCS
AP
0
8/27/2001
SLR
5288
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19430s12lbl.pdf
4/15/2003
AP
0
2/20/2002
SCS
AP
0
4/16/2002
SCE
AP
0
6/28/2002
SCM
AP
0
8/21/2002
SCS
AP
0
12/19/2002
SCS
AP
0
12/17/2003
SLR
7294
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19430slr025ltr.pdf
12/22/2003
AP
0
9/26/2008
SLR
20904
044
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019430s044ltr.pdf
10/1/2008
AP
0
9/26/2008
SLR
20932
044
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019430s044lbl.pdf
10/3/2008
AP
0
5/19/2009
SLR
22622
047
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019430s047ltr.pdf
5/26/2009
AP
0
8/20/2012
SLR
33534
053
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf
8/20/2012
AP
0
8/20/2012
SLR
33535
053
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019430Orig1s053ltr.pdf
8/22/2012
AP
0
7/23/2013
SCM
38281
054
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s054.pdf
1/15/2014
AP
0
9/16/2013
SCM
38288
055
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s055.pdf
1/16/2014
AP
0
11/8/2013
SCM
38289
056
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s056.pdf
1/16/2014
AP
0
12/13/2013
SCM
AP
0
7/17/2014
SLR
39903
058
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430orig1s058ltr.pdf
7/21/2014
AP
0
7/17/2014
SLR
40067
058
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/19430Orig1s058lbl.pdf
7/30/2014
AP
0
4/30/2014
SLR
39191
059
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430Orig1s059ltr.pdf
5/1/2014
AP
0
4/30/2014
SLR
39201
059
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019430s059lbl.pdf
5/2/2014
AP
0
3/3/2016
SCM
AP
0
5/18/2016
SLR
46073
061
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019430Orig1s061ltr.pdf
5/20/2016
AP
0
5/18/2016
SLR
46086
061
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf
5/20/2016
AP
0
8/15/2016
SCM
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