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FDA Drug Application 019462 by VALEANT PHARMS NORTH

Application Number019462
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARMS NORTH
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
AP010/15/1986N5521000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf 4/30/2003
AP012/12/1986SLR       
AP04/1/1987SLR       
AP010/17/1988SE1       
AP08/18/1988SCP       
AP011/23/1988SLR       
AP08/16/1991SCM       
AP011/30/1990SLR       
AP011/30/1990SLR       
AP012/10/1991SE1       
AP08/22/1997SLR       
AP011/30/1990SLR       
AP03/29/1996SLR       
AP03/29/1996SLR       
AP03/17/1995SCS       
AP03/29/1996SLR       
AP011/13/1996SCP       
AP02/6/1996SCM       
AP01/9/1997SCS       
AP08/12/1998SLR       
AP08/22/1997SLR       
AP011/25/1998SCM       
AP02/8/1999SCS       
AP010/8/1998SLR       
AP03/18/1999SLR1207027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf 3/18/1999
AP011/27/2000SLR       
AP04/25/2001SLR5447029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462s29lbl.pdf 4/24/2003
AP06/6/2002SE83356030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf 6/6/2002
AP06/6/2002SE83358030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf 6/6/2002
AP06/6/2002SE817184030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf 7/9/2007
AP03/14/2001SLR1607031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20752s6ltr.pdf 3/14/2001
AP04/29/2002SCS       
AP011/5/2007SLR18340034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf 11/7/2007
AP011/5/2007SLR18355034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf 11/8/2007
AP03/23/2010SLR25107035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019462s035ltr.pdf 3/25/2010
AP03/23/2010SLR25130035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019462s035lbl.pdf 3/26/2010
AP06/2/2011SLR29021037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019462s037ltr.pdf 6/3/2011
AP06/2/2011SLR29031037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019462s037lbl.pdf 6/7/2011
AP02/3/2014SLR38464038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019462s038lbl.pdf 2/6/2014
AP02/3/2014SLR38479038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019462Orig1s038ltr.pdf 2/10/2014




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