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Back to FDA Applications sponsored by LIEBEL-FLARSHEIM
FDA Drug Application 020975 by LIEBEL-FLARSHEIM
Application Number
020975
Application Type
New Drug Application
Sponsor Applicant
LIEBEL-FLARSHEIM
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
12/8/1999
N
2906
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf
12/8/1999
AP
0
12/8/1999
N
2907
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm
12/8/1999
AP
0
12/8/1999
N
4856
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf
12/8/1999
AP
0
12/8/1999
N
14268
000
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm
6/9/2006
AP
0
1/29/2001
SCS
AP
0
1/31/2003
S
7628
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937s3,20-975s3,20-976s3_OptiMark.cfm
1/29/2004
AP
0
1/31/2003
S
9292
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Approv.pdf
6/10/2004
AP
0
1/31/2003
S
9293
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf
6/10/2004
AP
0
11/23/2005
SCS
13161
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020975s007ltr.pdf
11/30/2005
AP
0
8/4/2006
SE8
14624
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf
8/7/2006
AP
0
8/4/2006
SE8
14635
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975, 020976s009LTR.pdf
8/7/2006
AP
0
8/15/2008
SLR
20648
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020975s010ltr.pdf
8/20/2008
AP
0
8/15/2008
SLR
20673
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020975s010lbl.pdf
8/26/2008
AP
0
9/4/2007
SLR
17748
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf
9/6/2007
AP
0
9/4/2007
SLR
17774
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011, 020976s011, 020975s012ltr.pdf
9/6/2007
AP
0
12/20/2010
SLR
27318
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020975s017lbl.pdf
12/20/2010
AP
0
12/20/2010
SLR
27336
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,020976s016ltr.pdf
12/22/2010
AP
0
5/21/2013
SLR
36128
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020975s022ltr.pdf020937Orig1s021,020975Orig1s022,020976Orig1s022ltr.pdf
5/23/2013
AP
0
5/21/2013
SLR
36134
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf
5/23/2013
AP
0
8/26/2013
SLR
36899
023
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022,%20020975Orig1s023,%20020976Orig1s024ltr.pdf
8/27/2013
AP
0
8/26/2013
SLR
36909
023
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020975s2302976s24lbl.pdf
8/27/2013
AP
0
8/7/2014
SLR
40182
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf
8/8/2014
AP
0
8/7/2014
SLR
40196
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s023,020975Orig1s024,020976Orig1s025ltr.pdf
8/11/2014
AP
0
11/24/2014
SLR
41094
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26lbl.pdf
11/26/2014
AP
0
11/24/2014
SLR
41101
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975Origs025,020976Orig1s026ltr.pdf
11/26/2014
AP
0
8/29/2016
SLR
46934
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020937Orig1s026,020975Orig1s027,020976Orig1s028ltr.pdf
9/1/2016
AP
0
8/29/2016
SLR
46953
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf
9/2/2016
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