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FDA Drug Application 050541 by ALCON LABS INC

Application Number050541
Application Type New Drug Application
Sponsor ApplicantALCON LABS INC
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
AP012/12/1980N       
AP06/13/1995SCP       
AP06/13/1994SLR       
AP07/27/1994SCS       
AP011/1/1995SCS       
AP011/1/1995SCS       
AP03/5/1996SCS       
AP06/25/1996SCM       
AP01/15/1998SCM       
AP08/4/1998SCS       
AP012/18/1998SCM       
AP03/11/1999SCS       
AP02/5/1999SCM       
AP08/17/1999SCS       
AP02/18/2000SCM       
AP07/22/2003SLR6146017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50541slr017_tobrex_lbl.pdf 7/28/2003
AP07/22/2003SLR6147017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50541slr017ltr.pdf 7/28/2003
AP05/2/2002SCS       
AP012/4/2002SCS       
AP012/18/2012SCM       
AP012/14/2012SLR34706024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050541Orig1s024ltr.pdf 12/19/2012
AP012/14/2012SLR34816024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050541s024lbl.pdf 1/2/2013




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