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Back to FDA Applications sponsored by ANI PHARMS
FDA Drug Application 008381 by ANI PHARMS
Application Number
008381
Application Type
New Drug Application
Sponsor Applicant
ANI PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New ester, new salt, or other noncovalent derivative
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
4/11/1952
N
AP
0
4/18/1984
SPD
AP
0
4/18/1984
SCF
AP
0
4/18/1984
SE1
AP
0
5/29/1986
SCS
AP
0
7/27/1985
SCS
AP
0
11/4/1985
SLR
AP
0
9/8/1986
SLR
AP
0
3/2/1987
SLR
AP
0
4/6/1988
SLR
AP
0
6/30/1988
SCS
AP
0
12/13/1989
SCM
AP
0
12/12/1989
SCM
AP
0
2/6/1992
SCS
AP
0
3/30/1992
SCM
AP
0
5/6/1998
SCM
AP
0
6/27/2003
S
6029
026
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf
7/6/2003
AP
0
6/27/2003
SLR
6028
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf
7/6/2003
AP
0
4/2/2008
SCM
19630
028
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf
4/9/2008
AP
0
4/2/2008
SCM
19660
028
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf
4/16/2008
AP
0
11/10/2008
SLR
21206
030
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf
11/12/2008
AP
0
11/10/2008
SLR
21219
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008381s030ltr.pdf
11/13/2008
Back to FDA Applications sponsored by ANI PHARMS