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FDA Drug Application 018057 by HQ SPCLT PHARMA

Application Number018057
Application Type New Drug Application
Sponsor ApplicantHQ SPCLT PHARMA
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
AP012/19/1978N       
AP09/11/1979SCM       
AP012/18/1979SLR       
AP012/5/1979SCM       
AP01/31/1980SCM       
AP01/31/1980SLR       
AP02/26/1980SLR       
AP01/22/1981SCE       
AP09/16/1980SLR       
AP07/4/1980SCP       
AP03/12/1981SLR       
AP012/29/1981SES       
AP06/10/1982SCM       
AP01/13/1983SCS       
AP02/27/1984SLR       
AP05/2/1986SCS       
AP08/23/1985SLR       
AP07/18/1984SCS       
AP04/4/1984SCS       
AP010/31/1983SLR       
AP02/11/1988SCE       
AP03/5/1985SCS       
AP03/5/1985SCS       
AP07/3/1985SLR       
AP09/16/1985SCM       
AP03/5/1987SCP       
AP01/22/1986SLR       
AP08/26/1986SLR       
AP06/8/1987SCM       
AP08/19/1986SLR       
AP011/6/1986SLR       
AP03/23/1987SLR       
AP05/5/1988SCM       
AP01/13/1988SCM       
AP04/10/1987SLR       
AP011/8/1988SCS       
AP03/2/1989SLR       
AP01/12/1988SCS       
AP012/11/1990SLR       
AP04/4/1990SCM       
AP011/27/1991SCS       
AP09/27/1990SCS       
AP07/27/1992SLR       
AP07/11/1991SCS       
AP05/29/1990SCS       
AP011/1/1991SCP       
AP03/25/1993SLR       
AP04/22/1993SE2       
AP05/17/1993SLR       
AP012/13/1995SCM       
AP012/4/1995SCM       
AP08/9/1995SLR       
AP04/18/1996SCM       
AP05/5/1999SLR       
AP09/13/2000SCP       
AP01/16/2001SCM       
AP011/8/2002SLR3488076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18057slr076ltr.pdf 11/8/2002
AP09/2/2010SLR26368079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018057s079ltr.pdf 9/7/2010
AP09/2/2010SLR26408079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018057s079lbl.pdf 9/7/2010
AP08/26/2011SLR29917080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s080lbl.pdf 8/30/2011
AP08/26/2011SLR29928080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018057s080ltr.pdf 8/31/2011
AP012/29/2011SLR31333081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018057s081ltr.pdf 1/3/2012
AP012/29/2011SLR31377081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf 1/11/2012
AP02/6/2014SCM       
AP02/26/2015SLR41945083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018057Orig1s083ltr.pdf 2/27/2015
AP02/26/2015SLR41971083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018057s083lbl.pdf 3/2/2015
AP03/3/2015SCM       
AP010/6/2015SCM       




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