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FDA Drug Application 005010 by US PHARM HOLDINGS

Application Number005010
Application Type New Drug Application
Sponsor ApplicantUS PHARM HOLDINGS
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
AP011/10/1942N       
AP01/18/1974SLR       
AP05/4/1976SLR       
AP08/10/1976SCF       
AP01/4/1978SCM       
AP012/2/1977SCS       
AP07/27/1978SLR       
AP07/21/1978SLR       
AP07/26/1979SLR       
AP09/7/1982SCS       
AP03/28/1983SCP       
AP03/28/1983SCP       
AP03/28/1983SCS       
AP03/28/1983SCS       
AP03/28/1983SLR       
AP03/28/1983SCS       
AP01/17/1984SCS       
AP05/20/1985SCS       
AP05/20/1985SCM       
AP06/4/1985SCS       
AP05/12/1986SCS       
AP07/18/1986SLR       
AP01/6/1988SLR       
AP07/24/1997SLR       
AP04/3/1989SCP       
AP05/25/1989SCM       
AP05/24/1989SCM       
AP01/25/1990SCM       
AP09/12/1990SCM       
AP02/12/1991SCM       
AP07/30/1992SCP       
AP09/29/1992SCS       
AP09/29/1992SCS       
AP09/10/1992SCS       
AP03/16/1995SCP       
AP03/16/1995SCS       
AP03/16/1995SCP       
AP010/10/1995SCS       
AP010/17/2000SCS       
AP02/26/2003SLR4256047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/05010slr047ltr.pdf 3/10/2003
AP05/15/2003SLR5782048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/05010slr048ltr.pdf 6/8/2003
AP03/5/2009SLR21967049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/005010s049ltr.pdf 3/10/2009
AP03/5/2009SLR22012049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005010s049lbl.pdf 3/17/2009
AP04/11/2011SLR28524050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s050lbl.pdf 4/11/2011
AP04/11/2011SLR28533050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005010s050ltr.pdf 4/13/2011
AP010/31/2011SLR30463051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005010s051ltr.pdf 11/2/2011
AP010/31/2011SLR30478051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s051lbl.pdf 10/31/2011




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