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FDA Drug Application 019851 by US PHARMS HOLDINGS I

Application Number019851
Application Type New Drug Application
Sponsor ApplicantUS PHARMS HOLDINGS I
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
AP06/25/1991N14270000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP01/9/1992SLR       
AP03/13/1992SCP       
AP06/25/1992SLR       
AP011/20/1992SLR       
AP010/21/1993SLR       
AP03/15/1994SCS       
AP05/5/1995SLR       
AP02/8/1995SCS       
AP011/22/1995SLR       
AP07/7/1995SCS       
AP011/2/1995SCM       
AP06/25/1996SCP       
AP01/13/1997SCE       
AP04/18/1997SCP       
AP08/13/1997SCP       
AP07/29/1998SLR       
AP07/20/1998SCS       
AP04/28/1999SCP       
AP05/10/2000SCM       
AP011/2/2000SCM       
AP012/14/2001SLR       
AP08/13/2001SCP       
AP011/30/2001SCS       
AP04/29/2002SCM       
AP09/20/2002SCM       
AP010/25/2002SCS       
AP03/2/2004SE57809028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19851se5-028ltr.pdf 3/3/2004
AP03/2/2004SE58195028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/019851s028lbl.pdf 4/5/2004
AP010/29/2003SLR6870029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19851slr029,20033slr025ltr.pdf 11/5/2003
AP02/2/2007SLR15803034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019851s034, 020033s033ltr.pdf 2/12/2007
AP05/29/2008SLR19910036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019851s036, 020033s036ltr.pdf 6/2/2008
AP01/22/2009SLR21680037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s037,020033s037ltr.pdf 1/26/2009
AP011/10/2009SLR23908038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019851s038lbl.pdf 11/16/2009
AP011/10/2009SLR24464038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s038ltr.pdf 1/7/2010
AP06/14/2011SLR29159040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019851s040ltr.pdf 6/16/2011
AP06/14/2011SLR29177040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019851s040lbl.pdf 6/16/2011
AP05/17/2012SLR32722042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851Orig1s042ltr.pdf 5/21/2012
AP05/17/2012SLR32735042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf 5/22/2012
AP01/19/2012SLR31452043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s043lbl.pdf 1/23/2012
AP01/19/2012SLR31660043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043,020033s045ltr.pdf 2/6/2012
AP09/21/2012SLR33837044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s044lbl.pdf 9/25/2012
AP07/22/2015SLR43460045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s045,s049ltr.pdf 7/23/2015
AP07/22/2015SLR43479045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf 7/24/2015
AP012/12/2014SLR41249046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019851Orig1s046ltr.pdf 12/15/2014
AP012/12/2014SLR41270046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019851s046lbl.pdf 12/16/2014
AP01/26/2015SLR41691047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s047ltr.pdf 1/27/2015
AP01/26/2015SLR41742047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s047lbl.pdf 1/30/2015
AP07/14/2015SCM       
AP07/22/2015SLR43461049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s045,s049ltr.pdf 7/23/2015
AP07/22/2015SLR43480049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf 7/24/2015
AP012/17/2015SCM       




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