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FDA Drug Application 012209 by SPECTRUM PHARMS

Application Number012209
Application Type New Drug Application
Sponsor ApplicantSPECTRUM PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/25/1962N       
AP07/22/1975SCS       
AP09/27/1976SCS       
AP09/27/1976SCP       
AP09/29/1976SCS       
AP05/3/1977SLR       
AP09/29/1978SLR       
AP01/10/1983SCS       
AP011/8/1979SCS       
AP04/4/1980SCM       
AP03/24/1982SLR       
AP05/12/1983SLR       
AP011/26/1986SPD       
AP07/19/1984SLR       
AP07/1/1986SLR       
AP06/26/1985SCM       
AP011/26/1986SLR       
AP010/21/1986SCM       
AP05/19/1988SCS       
AP010/3/1988SLR       
AP03/20/1989SCM       
AP05/20/1991SLR       
AP010/18/1991SCS       
AP05/12/1994SLR       
AP05/5/1995SCE       
AP09/15/1997SCS       
AP01/20/1999SCP1860038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/12209-S038_Fluorouracil.pdf 1/20/1999
AP07/31/2000SCS       
AP07/29/2016SE846693040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf 8/2/2016
AP07/29/2016SE846706040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012209Orig1s040ltr.pdf 8/2/2016




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