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FDA Drug Application 012041 by APOTHECON

Application Number012041
Application Type New Drug Application
Sponsor ApplicantAPOTHECON
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/4/1960N       
AP012/28/1978SLR       
AP01/12/1982SLR       
AP09/19/1977SCS       
AP07/17/1979SCM       
AP05/20/1980SCS       
AP08/21/1979SCS       
AP04/1/1981SCS       
AP012/3/1985SCM       
AP011/30/1987SCM       
AP011/19/1986SCM       
AP07/19/1991SCP       
AP09/25/1991SCS       
AP010/6/1993SLR       
AP08/30/1993SCP       
AP08/30/1993SCP       
AP01/10/1995SCS       
AP05/22/1996SCS       
AP02/3/1998SCS       
AP011/20/2006SLR15385033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/012041s033lbl.pdf 11/22/2006
AP011/20/2006SLR15443033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012041s033ltr.pdf 12/4/2006
AP06/15/2001SCM       
AP01/28/2010SLR24711036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012041s036,014901s037lbl.pdf 2/4/2010
AP01/28/2010SLR24737036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012041s036,014901s037ltr.pdf 2/5/2010
AP06/16/2011SLR29197038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s038lbl.pdf 6/16/2011
AP06/16/2011SLR29208038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s038,014901s038ltr.pdf 6/17/2011
AP06/16/2011SLR31916038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/012041Orig1s038.pdf 2/28/2012
AP07/15/2011SLR29531039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012041s039lbl.pdf 7/18/2011
AP07/15/2011SLR29537039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012041s039,014901s039ltr.pdf 7/19/2011
AP07/3/2014SLR39792042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012041Orig1s042,014901Orig1s042ltr.pdf 7/8/2014
AP07/3/2014SLR39820042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012041s042lbledt.pdf 7/9/2014
AP010/26/2015SCM       




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