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FDA Drug Application 020828 by HOFFMANN LA ROCHE

Application Number020828
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/7/1997N24961000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020828_fortovase_toc.cfm 3/4/2010
AP08/5/1998SLR       
AP09/9/1998SCM       
AP02/12/1999SCS       
AP012/4/1998SCS       
AP03/18/1999SCM17409006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020828_S006_FORTOVASE.pdf 7/27/2007
AP09/8/1999SCS       
AP011/13/2000SLR       
AP09/22/2000SCS       
AP07/2/2002SLR1953010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20828s010ltr.pdf 7/2/2002
AP07/2/2002SLR1954010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20828s10lbl.pdf 7/2/2002
AP03/28/2002SCS       
AP012/24/2003SE217408015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020828_S015_FORTOVASE.pdf 7/27/2007
AP012/24/2003SE27512015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20828se2-015ltr.pdf 1/14/2004
AP012/24/2003SE27554015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20828se2-015_fortovase_lbl.pdf 1/15/2004
AP012/24/2003SE27676015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20828s015ppi.pdf 2/3/2004
AP09/8/2005SLR12769019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf 9/14/2005
AP09/8/2005SLR12774019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf 9/14/2005
AP09/8/2005SLR13028019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020828s019lbl.pdf 11/4/2005
AP09/8/2005SLR17407019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020828_S019_FORTOVASE.pdf 7/27/2007
AP09/8/2005SLR13029020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020828s019lbl.pdf 11/4/2005
AP09/8/2005SLR17406020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020828_S020_FORTOVASE.pdf 7/27/2007
AP09/8/2005SLR12775020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf 9/14/2005
AP09/8/2005SLR12770020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf 9/14/2005




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