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FDA Drug Application 050095 by AKORN

Application Number050095
Application Type New Drug Application
Sponsor ApplicantAKORN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/2/1971N       
AP08/5/1983SLR       
AP08/23/1983SLR       
AP09/26/1983SLR       
AP01/18/1985SLR       
AP012/9/1986SLR       
AP05/26/1987SLR       
AP07/8/1987SLR       
AP05/26/1987SLR       
AP09/12/1988SLR       
AP012/20/1971SCE       
AP02/25/1972SLR       
AP08/29/1972SCE       
AP07/18/1973SLR       
AP08/28/1973SCE       
AP09/20/1974SCE       
AP09/23/1975SCE       
AP010/28/1975SLR       
AP09/14/1976SCE       
AP012/3/1976SLR       
AP09/12/1977SLR       
AP09/21/1977SCE       
AP011/3/1978SCE       
AP01/25/1980SCE       
AP06/3/1980SLR       
AP02/11/1981SCE       
AP03/4/1981SCM       
AP03/11/1981SLR       
AP05/29/1981SCM       
AP04/12/1982SCM       
AP08/31/1982SCE       
AP08/5/1983SLR       
AP08/23/1983SLR       
AP09/26/1983SCE       
AP01/18/1985SCM       
AP03/6/1987SCS       
AP05/26/1987SLR       
AP07/8/1987SLR       
AP08/12/1987SLR       
AP010/3/1996SLR       
AP012/21/1995SCM       
AP010/5/2001SCS       
AP06/11/2003SLR5980044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50095slr044ltr.pdf 6/22/2003
AP06/11/2003SLR5982044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50095slr044_capastat_lbl.pdf 6/22/2003
AP07/24/2008SLR20299062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050095s062ltr.pdf 7/25/2008
AP07/24/2008SLR20309062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050095s062lbl.pdf 7/29/2008




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