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FDA Drug Application 011145 by OAK PHARMS AKORN

Application Number011145
Application Type New Drug Application
Sponsor ApplicantOAK PHARMS AKORN
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
AP09/4/1958N       
AP03/27/1975SOA       
AP03/27/1975SOA       
AP012/12/1975SCS       
AP01/12/1976SCS       
AP010/31/1979SLR       
AP05/2/1977SCP       
AP02/15/1978SCP       
AP07/31/1978SLR       
AP010/31/1979SLR       
AP010/31/1979SLR       
AP03/9/1979SCS       
AP010/31/1979SLR       
AP010/31/1979SLR       
AP07/13/1979SLR       
AP010/31/1979SLR       
AP010/31/1979SLR       
AP011/14/1980SCP       
AP01/13/1981SLR       
AP01/13/1981SLR       
AP05/8/1987SPD       
AP06/17/1981SCP       
AP011/3/1981SCM       
AP07/14/1981SCP       
AP04/19/1982SCM       
AP03/1/1983SCP       
AP03/6/1984SLR       
AP03/6/1984SLR       
AP08/30/1984SCP       
AP08/28/1984SLR       
AP09/24/1984SLR       
AP010/11/1984SCP       
AP08/27/1985SCP       
AP010/11/1984SCP       
AP011/4/1985SLR       
AP01/13/1986SLR       
AP01/14/1986SLR       
AP012/8/1986SCM       
AP03/2/1993SLR       
AP03/2/1993SLR       
AP05/30/1989SCM       
AP02/16/1994SLR       
AP03/2/1993SLR       
AP03/31/1994SLR       
AP03/16/1994SCM       
AP05/23/1995SLR       
AP05/23/1995SLR       
AP011/29/1995SCM       
AP012/9/1998SLR       
AP05/5/1997SCM       
AP09/5/1997SCS       
AP09/8/1999SCF       
AP011/8/2002SCM       
AP09/23/2004SLR10281090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf 9/29/2004
AP09/23/2004SLR10282091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s090,091,11870s036ltr.pdf 9/29/2004
AP010/22/2004SLR10472092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11145s092ltr.pdf 10/29/2004
AP08/10/2005SLR12577093   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011145s093,011870s037ltr.pdf 8/11/2005
AP03/20/2013SCM       




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