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FDA Drug Application 019221 by VALEANT INTL

Application Number019221
Application Type New Drug Application
Sponsor ApplicantVALEANT INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/31/1986N       
AP01/30/1987SLR       
AP01/10/1989SLR       
AP04/18/1989SLR       
AP012/22/1989SCM       
AP011/30/1989SLR       
AP03/9/1990SLR       
AP02/6/1991SLR       
AP09/30/1992SCP       
AP05/7/1992SLR       
AP05/13/1992SLR       
AP09/30/1992SLR       
AP07/31/1996SLR       
AP02/24/1993SLR       
AP07/12/1995SE2       
AP01/14/1994SLR       
AP05/11/1994SLR       
AP010/21/1993SLR       
AP02/18/1994SLR       
AP07/25/1994SLR       
AP09/28/1995SLR       
AP07/12/1995SCF       
AP06/11/1997SLR4349023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019221_s023ap.pdf 6/11/1997
AP010/13/1998SLR651024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19221s024.pdf 10/13/1998
AP02/17/1999SLR3909025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf 6/22/2001
AP011/27/2001SLR2256026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998s058_Vasotec.cfm 11/27/2001
AP011/27/2001SLR5194026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_Approv.pdf 11/27/2001
AP011/27/2001SLR5195026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf 11/27/2001
AP011/1/2002SLR2238027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19221slr027,19309slr025ltr.pdf 10/30/2002
AP02/4/2002SCM       
AP010/15/2002SCM       
AP010/31/2007SLR18365037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018998s070, 019221s037ltr.pdf 11/8/2007
AP09/25/2008SLR20899038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018998s071, 019221s038ltr.pdf 9/29/2008
AP03/11/2011SLR28238041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019221s041lbl.pdf 3/14/2011
AP03/11/2011SLR28266041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019221s041ltr.pdf 3/16/2011
AP02/17/2012SLR31845042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s042lbl.pdf 2/22/2012
AP02/17/2012SLR31868042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019221s042ltr.pdf 2/23/2012
AP09/13/2012SLR33755043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019221s043lbl.pdf 9/14/2012
AP09/13/2012SLR33765043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019221Orig1s043ltr.pdf 9/17/2012
AP012/24/2014SLR41443044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019221Orig1s044ltr.pdf 12/30/2014
AP012/24/2014SLR41598044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019221s044lbl.pdf 1/9/2015
AP08/25/2015SLR43720045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019221s045lbl.pdf 8/26/2015
AP08/25/2015SLR43727045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019221Orig1s045ltr.pdf 8/27/2015




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