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FDA Drug Application 011525 by AKORN

Application Number011525
Application Type New Drug Application
Sponsor ApplicantAKORN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/9/1959N       
AP08/2/1989SCM       
AP06/5/1991SLR       
AP03/30/1995SCS       
AP03/30/1995SCS       
AP010/21/1997SCM       
AP03/2/1998SCS       
AP09/22/2006SLR14972017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011525s017lbl.pdf 9/25/2006
AP09/22/2006SLR15021017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011525s017LTR.pdf 9/27/2006
AP010/5/2015SLR44177027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011525s027lbl.pdf 10/8/2015




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