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FDA Drug Application 018086 by ATON

Application Number018086
Application Type New Drug Application
Sponsor ApplicantATON
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
AP08/17/1978N       
AP01/8/1980SLR       
AP01/2/1980SLR       
AP04/6/1979SLR       
AP012/3/1979SLR       
AP07/20/1979SLR       
AP05/13/1980SFP       
AP02/11/1980SLR       
AP05/21/1980SLR       
AP06/20/1980SCS       
AP07/15/1981SCM       
AP03/31/1981SFP       
AP08/4/1987SPD       
AP010/9/1981SLR       
AP010/9/1981SCS       
AP010/27/1981SCM       
AP011/3/1981SLR       
AP06/30/1982SCM       
AP09/7/1983SCS       
AP06/14/1984SCM       
AP02/12/1986SCM       
AP011/29/1984SCM       
AP08/4/1987SLR       
AP02/27/1986SLR       
AP06/5/1987SCS       
AP011/28/1986SCM       
AP08/4/1987SLR       
AP08/4/1987SLR       
AP01/15/1988SCM       
AP05/20/1992SLR       
AP03/19/1990SCS       
AP05/20/1992SLR       
AP05/20/1992SLR       
AP012/9/1993SLR       
AP02/24/1995SLR       
AP02/24/1995SLR       
AP04/25/1995SCP       
AP07/18/1996SCS       
AP05/16/1997SLR6630047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-086S047.pdf 9/11/2003
AP04/16/1996SCM       
AP04/22/1998SCM       
AP012/2/1996SCS       
AP08/5/1997SLR       
AP03/18/1998SLR6631052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-086S052.pdf 9/11/2003
AP09/18/2000SLR       
AP04/12/2001SCP5611054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18086S54lbl.pdf 4/12/2001
AP04/12/2001SCP9574054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086S54ltr.pdf 6/28/2004
AP011/30/2001SLR       
AP012/5/2001SCM       
AP04/29/2002SLR3980058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086s058.pdf 4/29/2002
AP04/29/2002SLR3981058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18086s58lbl.pdf 4/29/2002
AP04/17/2002SCS       
AP012/22/2003SCS7413060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18086scs060ltr.pdf 12/24/2003
AP012/22/2003SCS7425060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18086scs060_timoptic_lbl.pdf 12/29/2003
AP012/22/2003SCS14066060   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018086_s060_TimopticTOC.cfm 5/8/2006
AP012/6/2002SCP       
AP04/26/2006SLR13995070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf 5/1/2006
AP04/26/2006SLR14035070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf 5/1/2006
AP04/26/2006SLR13996072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf 5/1/2006
AP04/26/2006SLR14036072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf 5/1/2006
AP09/30/2011SLR30179075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018086s075lbl.pdf 9/30/2011
AP09/30/2011SLR30204075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018086s075ltr.pdf 10/3/2011
AP08/9/2016SLR46758076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018086Orig1s076ltr.pdf 8/10/2016
AP08/9/2016SLR46765076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018086s076lbl.pdf 8/10/2016




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