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Back to FDA Applications sponsored by MEDA PHARMS
FDA Drug Application 020114 by MEDA PHARMS
Application Number
020114
Application Type
New Drug Application
Sponsor Applicant
MEDA PHARMS
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
11/1/1996
N
AP
0
9/29/1997
SLR
AP
0
2/16/1999
SLR
AP
0
10/13/2000
SCM
AP
0
5/30/2000
SE1
1335
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S5LTR.PDF
5/30/2000
AP
0
9/15/2000
SE5
1464
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S06ltr.pdf
9/15/2000
AP
0
9/15/2000
SE5
8755
006
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20114S006_Astelin.cfm
5/27/2004
AP
0
6/27/2001
SCS
AP
0
2/17/2006
SE2
AP
0
8/10/2007
SLR
17607
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020114s017ltr.pdf
8/14/2007
AP
0
1/20/2012
SLR
31460
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020114s023ltr.pdf
1/23/2012
AP
0
1/20/2012
SLR
31505
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020114s023lbl.pdf
1/24/2012
AP
0
3/13/2014
SCM
AP
0
10/23/2014
SLR
40875
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020114Orig1s026ltr.pdf
10/24/2014
AP
0
10/23/2014
SLR
40984
026
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020114s026lbl.pdf
11/13/2014
Back to FDA Applications sponsored by MEDA PHARMS