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Back to FDA Applications sponsored by TEVA PHARMS USA
FDA Drug Application 050577 by TEVA PHARMS USA
Application Number
050577
Application Type
New Drug Application
Sponsor Applicant
TEVA PHARMS USA
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
5/7/1982
N
AP
0
11/17/1986
SLR
AP
0
4/22/1988
SLR
AP
0
8/11/1994
SCS
AP
0
6/14/1993
SCS
AP
0
9/27/1994
SCM
AP
0
6/29/1995
SCS
AP
0
5/5/1999
SLR
AP
0
12/30/2002
SLR
6212
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf
7/30/2003
AP
0
4/3/2000
SCS
AP
0
1/22/2003
SLR
4843
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf
1/22/2003
AP
0
10/22/2002
SCS
AP
0
12/4/2012
SCM
AP
0
12/4/2012
SCM
AP
0
12/4/2012
SCM
AP
0
8/9/2013
SCM
AP
0
12/12/2012
SCM
AP
0
7/31/2014
SCM
AP
0
9/23/2014
SCM
AP
0
1/5/2015
SCM
AP
0
1/5/2015
SCM
Back to FDA Applications sponsored by TEVA PHARMS USA