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FDA Drug Application 018469 by ALCON

Application Number018469
Application Type New Drug Application
Sponsor ApplicantALCON
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
AP010/28/1981N       
AP02/25/1982SCP       
AP06/8/1982SCS       
AP06/8/1982SCM       
AP011/14/1983SCS       
AP01/24/1986SCP       
AP06/17/1985SCS       
AP010/22/1985SCS       
AP02/13/1986SCP       
AP03/27/1987SCS       
AP09/29/1986SCS       
AP09/10/1987SCP       
AP06/8/1988SCP       
AP011/17/1988SLR       
AP09/30/1988SCS       
AP011/30/1988SCP       
AP03/24/1993SCS       
AP011/8/1988SCP       
AP010/24/1989SCP       
AP06/29/1990SLR       
AP06/15/1993SCM       
AP06/29/1990SCS       
AP03/23/1992SCS       
AP012/30/1991SCS       
AP06/8/1993SLR       
AP08/19/1994SCM       
AP07/13/1994SLR       
AP01/14/1997SCS       
AP05/2/1997SCS       
AP012/29/1998SLR       
AP011/3/1997SCS       
AP03/20/1998SCM       
AP010/18/1999SCS       
AP07/16/2003SCP6166036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18469scp036,slr037ltr.pdf 7/28/2003
AP07/16/2003SLR6167037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18469scp036,slr037ltr.pdf 7/28/2003
AP05/25/2004SLR8675038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469SLR038,039ltr.pdf 5/27/2004
AP05/25/2004SLR8684038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pdf 5/27/2004
AP05/25/2004SCP8685039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469SLR038,039_bss_lbl.pdf 5/27/2004
AP05/25/2004SCP8676039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469SLR038,039ltr.pdf 5/27/2004
AP012/20/2004SCP10864040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469s040,041ltr.pdf 12/30/2004
AP012/20/2004SCP10896040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf 12/30/2004
AP012/20/2004SLR10897041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18469s040,041lbl.pdf 12/30/2004
AP012/20/2004SLR10865041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18469s040,041ltr.pdf 12/30/2004
AP05/29/2013SCM42826052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf 5/14/2015
AP02/9/2015SCM       
AP011/6/2015SLR44449054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf 11/12/2015
AP011/6/2015SLR44838054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018469Orig1s054, 055ltr.pdf 12/22/2015
AP011/6/2015SCM44839055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018469Orig1s054, 055ltr.pdf 12/22/2015
AP011/6/2015SCM44450055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018469s054s055lbl.pdf 11/12/2015
AP04/27/2016SLR45795056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018469Orig1s056ltr.pdf 4/28/2016
AP04/27/2016SLR46345056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018469s056lbl.pdf 6/17/2016




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