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Back to FDA Applications sponsored by APIL
FDA Drug Application 204654 by APIL
Application Number
204654
Application Type
New Drug Application
Sponsor Applicant
APIL
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
7/24/2013
N
36616
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204654Orig1s000ltr.pdf
7/26/2013
AP
0
7/24/2013
N
36660
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204654s000lbl.pdf
7/30/2013
AP
0
7/24/2013
N
38694
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000TOC.cfm
3/6/2014
AP
0
7/24/2013
N
38695
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000SumR.pdf
3/6/2014
AP
0
4/16/2014
SCM
AP
0
5/20/2014
SCM
AP
0
10/7/2014
SCM
Back to FDA Applications sponsored by APIL