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FDA Drug Application 014399 by US PHARM HOLDINGS

Application Number014399
Application Type New Drug Application
Sponsor ApplicantUS PHARM HOLDINGS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/20/1964N16529000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP07/2/1974SCS       
AP04/4/1975SCS       
AP06/25/1976SES       
AP04/15/1975SCS       
AP05/28/1976SLR       
AP010/6/1975SLR       
AP02/14/1980SCF       
AP08/18/1980SLR       
AP07/28/1980SLR       
AP02/1/1982SCF       
AP02/11/1982SCF       
AP02/1/1982SCP       
AP02/1/1982SCS       
AP02/1/1982SCS       
AP06/22/1982SCS       
AP06/22/1982SCM       
AP04/29/1985SLR       
AP012/10/1990SLR       
AP06/24/1986SCS       
AP04/3/1987SCS       
AP011/15/1988SCP       
AP06/20/1988SCP       
AP03/30/1988SCM       
AP03/21/1989SCM       
AP012/10/1990SLR       
AP04/25/1990SCS       
AP06/19/1989SCM       
AP012/11/1991SLR       
AP012/11/1991SLR       
AP05/23/2000SLR       
AP09/3/1992SCM       
AP05/23/2000SLR       
AP05/23/2000SLR       
AP05/23/2000SLR       
AP01/12/2005SLR10963062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14399s062ltr.pdf 1/13/2005
AP01/12/2005SLR10964062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf 1/13/2005
AP04/11/2006SLR13891063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf 4/12/2006
AP04/11/2006SLR13911063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014399s063ltr.pdf 4/13/2006
AP07/30/2007SLR17425064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014399s064ltr.pdf 7/31/2007
AP07/30/2007SLR17436064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf 7/31/2007
AP010/26/2009SLR23702065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf 10/30/2009
AP010/26/2009SLR23703065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065MedGuide.pdf 10/30/2009
AP010/26/2009SLR23959065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014399s065ltr.pdf 11/19/2009
AP011/19/2012SLR34441066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf 11/21/2012
AP011/19/2012SLR34459066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf 11/26/2012
AP011/19/2012SLR34461066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf 11/26/2012
AP011/19/2012SLR34442067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf 11/21/2012
AP011/19/2012SLR34460067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf 11/26/2012
AP011/19/2012SLR34462067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf 11/26/2012
AP08/7/2014SCM       
AP07/2/2014SLR39739069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf 7/3/2014
AP07/2/2014SLR39740069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014399Orig1s069ltr.pdf 7/3/2014
AP09/29/2016SCM       




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