Back to FDA Applications sponsored by ALCON PHARMS LTD

FDA Drug Application 020816 by ALCON PHARMS LTD

Application Number020816
Application Type New Drug Application
Sponsor ApplicantALCON PHARMS LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/1/1998N298000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20816ltr.pdf 4/1/1998
AP04/1/1998N299000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20816lbl.pdf 4/1/1998
AP04/1/1998N5940000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020816_azopt.cfm 6/19/2003
AP02/5/1999SCM       
AP08/17/1999SCS       
AP06/2/2000SCM       
AP010/16/2001SCS       
AP07/12/2002SCS       
AP07/22/2003SLR6144006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20816slr006_azopt_lbl.pdf 7/28/2003
AP07/22/2003SLR6145006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20816slr006ltr.pdf 7/28/2003
AP09/28/2006SE815030009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020816s009LTR.pdf 10/2/2006
AP03/8/2011SLR28204012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020816s012ltr.pdf 3/10/2011
AP03/8/2011SLR28232012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020816s012lbl.pdf 3/11/2011
AP011/10/2015SLR44460019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020816s019lbl.pdf 11/12/2015
AP011/10/2015SLR44461019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020816Orig1s019ltr.pdf 11/13/2015




Back to FDA Applications sponsored by ALCON PHARMS LTD