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FDA Drug Application 019463 by ATON

Application Number019463
Application Type New Drug Application
Sponsor ApplicantATON
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
AP011/5/1986N       
AP08/9/1989SCM       
AP07/9/1990SCS       
AP05/21/1992SLR       
AP05/21/1992SLR       
AP03/25/1993SCS       
AP012/9/1993SLR       
AP01/18/1995SLR       
AP07/10/1995SCS       
AP05/16/1997SLR       
AP04/22/1998SCM       
AP012/2/1996SCM       
AP012/2/1996SCS       
AP08/14/1998SCM       
AP06/22/1997SCS       
AP03/18/1998SLR6636019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-463S019.pdf 9/11/2003
AP03/2/2000SLR       
AP03/2/2000SCM       
AP012/7/2001SLR5289022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19463s22lbl.pdf 4/15/2003
AP012/4/2001SCM       
AP07/26/2002SCS       
AP012/22/2003SLR7414026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19463slr026ltr.pdf 12/24/2003
AP012/22/2003SLR7427026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19463slr026_timoptic_lbl.pdf 12/29/2003
AP012/22/2003SLR14065026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019463_s026_TimopticTOC.cfm 5/8/2006
AP06/5/2006SLR14226027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019463s027lbl.pdf 6/6/2006
AP06/5/2006SLR14251027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019463s027LTR.pdf 6/8/2006
AP09/30/2011SLR30180028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019463s028lbl.pdf 9/30/2011
AP09/30/2011SLR30205028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019463s028ltr.pdf 10/3/2011
AP08/14/2015SCM       




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