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FDA Drug Application 050555 by ALCON

Application Number050555
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
AP011/25/1981N       
AP09/17/1992SCG       
AP02/3/1992SCS       
AP05/18/1994SLR       
AP011/29/1996SCS       
AP05/29/1998SCM       
AP02/5/1999SCM       
AP04/7/1999SCM       
AP09/28/1999SCP       
AP03/18/2003SLR4489017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf 3/26/2003
AP03/18/2003SLR4490017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf 3/26/2003
AP03/18/2003SCM4487018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf 3/26/2003
AP03/18/2003SCM4488018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf 3/26/2003
AP03/18/2003SLR4485019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50555slr017,019,scm018_Tobrex_lbl.pdf 3/26/2003
AP03/18/2003SLR4486019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50555slr017,019,scm018ltr.pdf 3/26/2003
AP07/15/2004SLR9755021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50555s021,022ltr.pdf 7/21/2004
AP07/15/2004SLR9824021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50555s021,022lbl.pdf 7/21/2004
AP07/15/2004SCP9756022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50555s021,022ltr.pdf 7/21/2004
AP07/15/2004SCP9825022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50555s021,022lbl.pdf 7/21/2004
AP09/10/2015SCM       




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