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Back to FDA Applications sponsored by ATNAHS PHARMA US
FDA Drug Application 018965 by ATNAHS PHARMA US
Application Number
018965
Application Type
New Drug Application
Sponsor Applicant
ATNAHS PHARMA US
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
Therapeutic Potential
Priority
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
3/23/1987
N
24023
000
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088657.pdf
11/19/2009
AP
0
1/27/1993
SCM
AP
0
9/12/1994
SCS
AP
0
4/14/2003
SLR
5700
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf
5/29/2003
AP
0
11/14/1996
SCM
AP
0
11/10/2004
SLR
10589
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf
11/16/2004
AP
0
11/10/2004
SLR
10605
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf
11/16/2004
AP
0
11/10/2004
SLR
10590
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf
11/16/2004
AP
0
11/10/2004
SLR
10606
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf
11/16/2004
AP
0
1/5/2001
SCM
AP
0
2/22/2002
SCM
AP
0
3/10/2006
SLR
13754
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf
3/14/2006
AP
0
3/10/2006
SLR
13810
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010,018965s013,018164s055, 017581s105ltr.pdf
3/23/2006
AP
0
1/24/2006
SLR
13486
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf
1/25/2006
AP
0
1/24/2006
SLR
13526
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf
1/30/2006
AP
0
4/19/2007
SLR
16319
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf
4/25/2007
AP
0
9/20/2007
SLR
17949
016
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf
9/25/2007
AP
0
9/20/2007
SLR
18018
016
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf
9/26/2007
AP
0
7/25/2008
SLR
20306
018
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf
7/29/2008
AP
0
7/25/2008
SLR
20321
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf
7/30/2008
AP
0
3/22/2013
SLR
35522
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf
3/26/2013
AP
0
3/22/2013
SLR
35549
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf
3/26/2013
AP
0
7/30/2015
SCM
AP
0
5/9/2016
SLR
45980
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf
5/11/2016
AP
0
5/9/2016
SLR
46008
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018965Orig1s022.s023ltr.pdf
5/12/2016
AP
0
5/9/2016
SLR
45979
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf
5/11/2016
AP
0
5/9/2016
SLR
46009
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018965Orig1s022.s023ltr.pdf
5/12/2016
AP
0
5/9/2016
SCM
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