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FDA Drug Application 022221 by AKORN

Application Number022221
Application Type New Drug Application
Sponsor ApplicantAKORN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/7/2008N20986000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022221s000ltr.pdf 10/9/2008
AP010/7/2008N21011000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022221lbl.pdf 10/9/2008
AP010/7/2008N23260000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022221_akten_toc.cfm 9/1/2009
AP010/7/2008N23261000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022221s000_SumR.pdf 9/1/2009
AP012/7/2012SCM34574002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022221s002lbl.pdf 12/10/2012
AP03/11/2014SLR38776005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022221Orig1s005ltr.pdf 3/13/2014
AP03/11/2014SLR38787005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022221s005lbl.pdf 3/13/2014




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