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FDA Drug Application 018060 by G AND W LABS

Application Number018060
Application Type New Drug Application
Sponsor ApplicantG AND W LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/9/1978N       
AP05/3/1978SLR       
AP010/6/1978SDS       
AP010/6/1978SDS       
AP010/5/1978SDS       
AP010/6/1978SDS       
AP010/5/1978SDS       
AP010/6/1978SDS       
AP010/5/1978SDS       
AP010/5/1978SDS       
AP010/5/1978SDS       
AP010/5/1978SDS       
AP010/6/1978SDS       
AP010/6/1978SDS       
AP010/6/1978SDS       
AP010/6/1978SDS       
AP08/31/1978SDS       
AP010/5/1978SDS       
AP03/15/1979SCM       
AP09/17/1979SCM       
AP03/6/1980SCP       
AP04/13/1979SDS       
AP09/14/1979SCP       
AP09/27/1979SCP       
AP010/24/1979SCP       
AP011/6/1979SCM       
AP09/12/1979SCP       
AP010/22/1979SLR       
AP011/5/1979SCP       
AP011/5/1979SLR       
AP011/6/1979SCP       
AP09/11/1979SLR       
AP02/20/1980SCM       
AP02/13/1980SLR       
AP02/13/1980SLR       
AP02/13/1980SLR       
AP02/21/1980SLR       
AP08/12/1980SLR       
AP011/19/1980SDS       
AP011/25/1980SCF       
AP011/21/1980SCS       
AP012/18/1980SCM       
AP04/22/1981SDS       
AP05/11/1983SCE       
AP012/17/1986SCF       
AP01/22/1985SCS       
AP010/20/1987SLR       
AP08/26/1987SLR       
AP03/31/1997SLR6629055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-060S055.pdf 9/11/2003
AP07/29/1996SCM       
AP03/24/1999SCS       
AP02/15/2002SCM       
AP04/28/2010SLR25439063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018060s063ltr.pdf 5/3/2010
AP04/1/2010SLR       
AP011/1/2011SLR30481065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018060s065ltr.pdf 11/3/2011
AP03/25/2014SLR38916066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018060Orig1s066ltr.pdf 3/27/2014
AP03/25/2014SLR39056066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018060Orig1s066lbl.pdf 4/16/2014
AP012/2/2014SCM       




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