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FDA Drug Application 019032 by PROMIUS PHARMA

Application Number019032
Application Type New Drug Application
Sponsor ApplicantPROMIUS 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
AP010/27/1986N       
AP02/17/1987SCS       
AP02/17/1987SCP       
AP04/29/1987SCM       
AP011/20/1987SCS       
AP012/28/1987SCP       
AP011/7/1988SCS       
AP06/9/1988SCP       
AP011/7/1988SLR       
AP05/11/1993SE1       
AP02/1/1990SLR       
AP011/29/1989SCS       
AP03/1/1991SCM       
AP09/17/1991SCS       
AP01/13/1998SCM       
AP03/12/2002SLR3924016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19032s16s17ltr.pdf 3/12/2002
AP03/12/2002SLR3925016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-032s16s17_Tenex.cfm 5/30/2002
AP03/12/2002SLR3926017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-032s16s17_Tenex.cfm 5/30/2002
AP03/12/2002SLR3927017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19032s16s17ltr.pdf 3/12/2002
AP07/3/2013SLR36450021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019032Orig1s021ltr.pdf 7/5/2013
AP07/3/2013SLR36464021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019032s021lbl.pdf 7/5/2013




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