Back to FDA Applications sponsored by US PHARMS HOLDINGS I

FDA Drug Application 020033 by US PHARMS HOLDINGS I

Application Number020033
Application Type New Drug Application
Sponsor ApplicantUS PHARMS HOLDINGS I
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
AP05/19/1992N       
AP06/23/1992SCP       
AP06/23/1992SCS       
AP01/7/1993SCP       
AP011/25/1992SLR       
AP010/21/1993SLR       
AP06/30/1993SCS       
AP012/20/1993SLR       
AP05/5/1995SLR       
AP04/2/1996SLR       
AP011/2/1995SCM       
AP01/13/1997SCE       
AP04/9/1997SLR       
AP07/29/1998SLR       
AP04/28/1999SCP       
AP010/16/2001SCM       
AP05/10/2000SCM       
AP012/14/2001SLR       
AP08/13/2001SCP       
AP011/30/2001SCS       
AP04/29/2002SCM       
AP09/20/2002SCM       
AP010/25/2002SCS       
AP010/29/2003SLR6871025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19851slr029,20033slr025ltr.pdf 11/5/2003
AP02/2/2007SLR15802033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019851s034, 020033s033ltr.pdf 2/12/2007
AP05/29/2008SLR19911036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019851s036, 020033s036ltr.pdf 6/2/2008
AP01/22/2009SLR21681037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s037,020033s037ltr.pdf 1/26/2009
AP011/10/2009SLR23860038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020033s038lbl.pdf 11/12/2009
AP011/10/2009SLR24529038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020033s038ltr.pdf 1/19/2010
AP03/17/2011SLR28269040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020033s040ltr.pdf 3/21/2011
AP03/17/2011SLR28293040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s040lbl.pdf 3/21/2011
AP06/14/2011SLR29163041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020033s041ltr.pdf 6/16/2011
AP06/14/2011SLR29175041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s041lbl.pdf 6/16/2011
AP02/16/2012SLR31811043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020033s043ltr.pdf 2/17/2012
AP02/16/2012SLR31827043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s043lbl.pdf 2/17/2012
AP01/19/2012SLR31453045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s045lbl.pdf 1/23/2012
AP01/19/2012SLR31661045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043,020033s045ltr.pdf 2/6/2012
AP07/26/2012SLR33293046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020033Orig1s046ltr.pdf 7/30/2012
AP07/26/2012SLR33313046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s046lbl.pdf 7/30/2012
AP09/21/2012SLR33838047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s047lbl.pdf 9/25/2012
AP07/22/2014SCM       
AP08/14/2014SCM       
AP012/12/2014SLR41248050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020033Orig1s050ltr.pdf 12/15/2014
AP012/12/2014SLR41271050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020033s050lbl.pdf 12/16/2014
AP07/7/2015SCM       
AP08/25/2015SLR43715052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020033s052lbl.pdf 8/26/2015
AP08/25/2015SLR43733052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020033Orig1s052ltr.pdf 8/27/2015
AP02/12/2016SCM       
AP06/3/2016SCM       
AP05/5/2016SCM       
AP09/23/2016SCM       
AP010/14/2016SCM       
AP010/14/2016SCM       




Back to FDA Applications sponsored by US PHARMS HOLDINGS I

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.