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FDA Drug Application 050616 by ALCON

Application Number050616
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
AP09/28/1988N       
AP06/27/1989SCS       
AP09/17/1992SCG       
AP08/31/1993SCS       
AP05/21/1992SLR       
AP02/3/1992SCS       
AP010/27/1994SLR       
AP03/18/1996SCS       
AP09/26/1996SLR6642009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/50-616S009.pdf 9/11/2003
AP011/29/1996SCS       
AP04/28/1999SLR       
AP05/29/1998SCM       
AP02/5/1999SCM       
AP04/7/1999SCM       
AP09/28/1999SCP       
AP03/18/2003SCM9575016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf 6/28/2004
AP03/18/2003SCM9576016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf 6/28/2004
AP03/18/2003SLR9577017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf 6/28/2004
AP03/18/2003SLR9578017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf 6/28/2004
AP012/11/2002SCS       
AP03/18/2003SLR4491019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50616scm016,slr017,019_tobraDex_lbl.pdf 3/26/2003
AP03/18/2003SLR4492019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50616scm016,slr017,019ltr.pdf 3/26/2003
AP07/15/2004SLR9826021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf 7/21/2004
AP07/15/2004SLR9753021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf 7/21/2004
AP07/15/2004SCP9754022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50616s021,022ltr.pdf 7/21/2004
AP07/15/2004SCP9827022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50616s021,022lbl.pdf 7/21/2004




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