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FDA Drug Application 020616 by ALLERGAN SALES LLC

Application Number020616
Application Type New Drug Application
Sponsor ApplicantALLERGAN SALES LLC
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
AP07/3/1996N33133000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311373.pdf 7/11/2012
AP07/3/1996N33134000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 7/11/2012
AP07/29/1997SLR27746001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020616S1_Kadian.pdf 2/4/2011
AP04/8/1998SCP       
AP07/16/1999SLR       
AP03/9/2001SCS       
AP02/28/2000SCF       
AP02/8/2001SCM       
AP012/21/2001SCS       
AP012/18/2001SCS       
AP03/28/2002SCS       
AP09/28/2005SCP12829010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020616s010lbl.pdf 9/30/2005
AP09/28/2005SCP12932010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020616s010ltr.pdf 10/20/2005
AP02/27/2007SCF15979017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017, s021ltr.pdf 3/7/2007
AP02/27/2007SCF15999017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf 3/7/2007
AP02/27/2007SCF18536017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020616_S017_KADIAN.pdf 11/19/2007
AP02/27/2007SLR15980021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s017, s021ltr.pdf 3/7/2007
AP02/27/2007SLR16000021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s017s021lbl.pdf 3/7/2007
AP02/27/2007SLR18535021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020616_S021_KADIAN.pdf 11/19/2007
AP010/27/2006SCF15300022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020616s022lbl.pdf 11/6/2006
AP010/27/2006SCF15317022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020616s022ltr.pdf 11/6/2006
AP04/20/2007SCF16295025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020616s025lbl.pdf 4/25/2007
AP04/20/2007SCF16420025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020616s025ltr.pdf 5/1/2007
AP07/9/2012SLR       
AP07/9/2012SLR33147041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020616Orig1s041ltr.pdf 7/11/2012
AP07/9/2012SLR33161041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s041lbl.pdf 7/12/2012
AP07/9/2012SCM33182044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020616s036s044lbl.pdf 7/13/2012
AP01/14/2013SCM       
AP04/15/2013SLR35735047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020616Orig1s047ltr.pdf 4/17/2013
AP03/27/2013SLR35574048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020616Orig1s048ltr.pdf 3/29/2013
AP04/16/2014SLR39067051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020616s051lbl.pdf 4/16/2014
AP04/16/2014SLR39077051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020616Orig1s051ltr.pdf 4/17/2014
AP04/14/2014SCM       
AP08/19/2014S40270053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020616Orig1s053ltr.pdf 8/20/2014
AP06/26/2015S43225054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020616Orig1s054ltr.pdf 7/2/2015
AP04/20/2016S45717055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s055ltr.pdf 4/22/2016
AP09/30/2016S47266058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020616Orig1s058ltr.pdf 10/4/2016




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