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Back to FDA Applications sponsored by LUPIN LTD
FDA Drug Application 202091 by LUPIN LTD
Application Number
202091
Application Type
New Drug Application
Sponsor Applicant
LUPIN LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New manufacturer
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
2/20/2013
N
35209
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202091Orig1s000ltr.pdf
2/21/2013
AP
0
2/20/2013
N
35212
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202091s000lbl.pdf
2/21/2013
AP
0
2/20/2013
N
38232
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000TOC.cfm
1/8/2014
AP
0
2/20/2013
N
38233
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000SumR.pdf
1/8/2014
AP
0
1/16/2014
SCM
AP
0
5/29/2014
SLR
39420
002
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202091Orig1s002ltr.pdf
6/2/2014
AP
0
5/29/2014
SLR
39445
002
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202091Orig1s002lbl.pdf
6/4/2014
AP
0
5/10/2016
SCM
AP
0
1/7/2016
SLR
44945
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202091Orig1s004,203195Orig1s005ltr.pdf
1/11/2016
AP
0
1/7/2016
SLR
44957
004
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf
1/12/2016
Back to FDA Applications sponsored by LUPIN LTD