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FDA Drug Application 019614 by RECRO GAINESVILLE

Application Number019614
Application Type New Drug Application
Sponsor ApplicantRECRO GAINESVILLE
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
AP05/29/1990N       
AP04/5/1994SCS       
AP08/18/1994SCE       
AP01/9/1992SCF       
AP06/6/1991SLR       
AP09/13/1991SLR       
AP010/12/1994SLR       
AP010/2/1992SLR       
AP010/2/1992SLR       
AP012/6/1993SLR       
AP03/30/1994SCP       
AP06/21/1995SLR       
AP011/8/1993SLR       
AP05/10/1996SCF       
AP08/2/1995SCE       
AP02/1/1996SCM       
AP05/16/1996SCM       
AP05/31/1996SCM       
AP05/31/1996SCM       
AP04/23/1997SCM       
AP012/30/1997SCS       
AP07/14/1998SLR       
AP07/29/1997SLR       
AP010/15/1998SCM       
AP06/5/1999SLR       
AP07/2/1999SCM       
AP012/13/1999SCM       
AP07/27/2000SCM       
AP011/29/2000SCM       
AP03/30/2010SLR25247034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf 4/9/2010
AP03/30/2010SLR25184045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf 4/2/2010
AP03/30/2010SLR25198045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019614s045lbl.pdf 4/4/2010
AP011/14/2011SLR30578049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019614s049lbl.pdf 11/14/2011
AP011/14/2011SLR30595049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019614s049ltr.pdf 11/16/2011
AP010/9/2014SLR40751050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019614Orig1s050ltr.pdf 10/10/2014
AP010/9/2014SLR40791050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019614s050lbl.pdf 10/15/2014




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