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FDA Drug Application 019901 by KING PHARMS

Application Number019901
Application Type New Drug Application
Sponsor ApplicantKING PHARMS
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
AP01/28/1991N14280000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP05/20/1991SCS       
AP05/20/1991SCS       
AP01/9/1992SCP       
AP05/18/1992SCS       
AP06/25/1992SLR       
AP01/8/1993SLR       
AP05/20/1993SCP       
AP01/14/1994SLR       
AP03/1/1995SLR       
AP08/22/1995SE1       
AP010/21/1994SLR       
AP08/22/1995SCS       
AP07/13/1995SLR       
AP07/13/1995SLR       
AP05/5/1995SCS       
AP01/29/1996SCP       
AP09/27/1995SCS       
AP03/13/1996SCS       
AP09/3/1996SLR       
AP011/25/1997SCM       
AP012/4/1997SCM       
AP02/25/1998SCM       
AP09/22/1998SCP       
AP09/24/1998SCP       
AP012/16/1998SLR1125025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19901s025_Altace.pdf 12/16/1998
AP02/29/2000SCM       
AP03/16/2000SCM       
AP010/4/2000SE111422028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019901_s028_Altace.cfm 4/15/2005
AP09/21/2000SCM       
AP05/25/2001SCS       
AP012/19/2000SCM       
AP03/28/2001SCM       
AP07/26/2001SCM       
AP08/2/2002SLR4371034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19901slr034ltr.pdf 8/2/2002
AP07/10/2002SCM4370035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19901scm035ltr.pdf 7/10/2002
AP010/15/2004SLR10447040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s040,041ltr.pdf 10/22/2004
AP010/15/2004SLR10448041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s040,041ltr.pdf 10/22/2004
AP010/15/2004SLR10446043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s043ltr.pdf 10/22/2004
AP011/15/2004SLR10612046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19901s046ltr.pdf 11/16/2004
AP011/15/2004SLR27861046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019901_s046_altace.pdf 2/15/2011
AP03/4/2009SLR21966052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s052,022021s001ltr.pdf 3/6/2009
AP02/9/2009SLR21847054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s054,022021s005ltr.pdf 2/18/2009
AP010/21/2010SLR26734055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019901s055ltr.pdf 10/25/2010
AP010/21/2010SLR26759055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019901s055lbl.pdf 10/25/2010
AP08/23/2011SLR29884058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019901s058ltr.pdf 8/26/2011
AP08/23/2011SLR29945058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019901s058lbl.pdf 9/2/2011
AP04/11/2012SLR32435059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019901s059ltr.pdf 4/16/2012
AP04/11/2012SLR32476059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019901s059lbl.pdf 4/20/2012
AP09/23/2013SLR37193060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s060lbl.pdf 9/23/2013
AP09/23/2013SLR37210060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s060ltr.pdf 9/24/2013
AP011/4/2013SLR37678062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s062lbl.pdf 11/4/2013
AP011/4/2013SLR37715062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s062ltr.pdf 11/6/2013
AP010/25/2013SLR37593063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019901Orig1s063ltr.pdf 10/28/2013
AP010/25/2013SLR37652063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s063lbl.pdf 10/31/2013
AP05/2/2014SLR39218064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019901Orig1s064ltr.pdf 5/6/2014
AP05/2/2014SLR39225064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019901s064lbl.pdf 5/6/2014
AP09/11/2015SLR43864065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019901Orig1s065ltr.pdf 9/14/2015
AP09/11/2015SLR43868065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019901s065lbl.pdf 9/14/2015




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