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Back to FDA Applications sponsored by ALLERGAN
FDA Drug Application 021565 by ALLERGAN
Application Number
021565
Application Type
New Drug Application
Sponsor Applicant
ALLERGAN
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
10/16/2003
N
6820
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21565ltr.pdf
10/14/2003
AP
0
10/16/2003
N
6827
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf
10/17/2003
AP
0
10/16/2003
N
7459
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-565_Elestat.cfm
12/31/2003
AP
0
8/15/2005
SCP
12611
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf
8/16/2005
AP
0
8/15/2005
SCP
12632
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021565s005ltr.pdf
8/19/2005
AP
0
12/20/2011
SLR
31222
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021565s006ltr.pdf
12/22/2011
AP
0
12/20/2011
SLR
31233
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf
12/23/2011
AP
0
6/17/2013
SCM
AP
0
2/25/2016
SCM
Back to FDA Applications sponsored by ALLERGAN