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Back to FDA Applications sponsored by ORGANON USA INC
FDA Drug Application 021187 by ORGANON USA INC
Application Number
021187
Application Type
New Drug Application
Sponsor Applicant
ORGANON USA INC
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
10/3/2001
N
3054
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21187ltr.pdf
10/3/2001
AP
0
10/3/2001
N
3055
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21187lbl.pdf
10/3/2001
AP
0
10/3/2001
N
3056
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-187_NuvaRing.cfm
10/3/2001
AP
0
3/27/2002
SCS
AP
0
5/29/2002
SCM
AP
0
2/5/2002
SCM
AP
0
11/5/2002
SCS
AP
0
2/4/2004
SLR
7759
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr007ltr.pdf
3/2/2004
AP
0
3/2/2004
SLR
7848
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr008ltr.pdf
3/10/2004
AP
0
7/29/2005
SE8
12504
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021187s012ltr.pdf
8/3/2005
AP
0
7/29/2005
SE8
12515
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021187s012lbl.pdf
8/3/2005
AP
0
10/2/2007
SLR
18120
017
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021187s017ltr.pdf
10/4/2007
AP
0
10/2/2007
SLR
18160
017
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf
10/4/2007
AP
0
4/29/2008
SLR
19762
018
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021187s018ltr.pdf
5/5/2008
AP
0
2/19/2016
SCM
AP
0
10/4/2013
SE8
37380
021
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s021lbl.pdf
10/8/2013
AP
0
10/4/2013
SE8
37471
021
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s021ltr.pdf
10/21/2013
AP
0
10/4/2013
SE8
41575
021
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf
1/9/2015
AP
0
10/4/2013
SE8
42081
021
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm
3/10/2015
AP
0
10/4/2013
SLR
37381
022
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf
10/8/2013
AP
0
10/4/2013
SLR
37472
022
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s022ltr.pdf
10/21/2013
AP
0
10/4/2013
SLR
41576
022
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf
1/9/2015
AP
0
10/4/2013
SLR
42432
022
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm
4/6/2015
AP
0
7/19/2013
SCM
AP
0
6/18/2014
SLR
39592
024
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s024ltr.pdf
6/19/2014
AP
0
6/18/2014
SLR
39623
024
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf
6/23/2014
AP
0
10/31/2014
SLR
40916
025
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s025ltr.pdf
11/3/2014
AP
0
10/31/2014
SLR
40965
025
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf
11/7/2014
AP
0
9/30/2016
SE8
47274
027
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021187Orig1s027ltr.pdf
10/4/2016
AP
0
9/30/2016
SE8
47303
027
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021187s027lbl.pdf
10/6/2016
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