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Back to FDA Applications sponsored by ANI PHARMS INC
FDA Drug Application 018553 by ANI PHARMS INC
Application Number
018553
Application Type
New Drug Application
Sponsor Applicant
ANI PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
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
4/19/1983
N
AP
0
1/9/1984
SES
AP
0
3/6/1984
SCM
AP
0
10/11/1984
SCS
AP
0
8/9/1984
SCE
23312
005
http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s005_INDERAL LA.pdf
9/14/2009
AP
0
3/21/1985
SLR
23313
006
http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s006_INDERAL LA.pdf
9/14/2009
AP
0
8/20/1985
SES
AP
0
1/7/1986
SCS
AP
0
4/2/1985
SCM
AP
0
11/20/1985
SCS
AP
0
3/4/1986
SCM
23314
012
http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s012_INDERAL LA.pdf
9/14/2009
AP
0
3/18/1987
SE2
23315
013
http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s013_INDERAL LA.pdf
9/14/2009
AP
0
5/27/1986
SCF
23316
015
http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s015_INDERAL LA.pdf
9/14/2009
AP
0
9/2/1986
SCS
AP
0
1/20/1987
SCP
AP
0
5/25/1988
SCP
AP
0
8/8/1988
SCS
AP
0
1/25/1989
SCP
AP
0
4/10/1989
SCS
AP
0
6/5/1989
SCM
AP
0
7/10/1989
SCE
AP
0
2/9/1990
SCF
AP
0
4/17/1990
SCS
AP
0
11/7/1997
SLR
AP
0
8/22/1999
SLR
AP
0
3/31/2000
SCM
AP
0
2/6/2002
SLR
AP
0
6/9/2004
SLR
9312
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18553slr030ltr.pdf
6/10/2004
AP
0
1/3/2007
SLR
15585
034
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s034ltr.pdf
1/8/2007
AP
0
2/21/2007
SLR
15952
035
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s035ltr.pdf
3/6/2007
AP
0
10/31/2007
SLR
18369
036
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s036ltr.pdf
11/8/2007
AP
0
3/17/2011
SLR
28302
037
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf
3/21/2011
AP
0
3/17/2011
SLR
28311
037
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018553s037ltr.pdf
3/23/2011
AP
0
10/22/2015
SCM
AP
0
12/21/2015
SCM
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