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FDA Drug Application 016087 by ROCHE

Application Number016087
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/24/1966N       
AP06/20/1974SLR       
AP06/5/1974SLR       
AP011/15/1974SCS       
AP012/2/1974SCS       
AP05/1/1975SCS       
AP011/13/1975SCS       
AP04/23/1976SCP       
AP07/23/1976SCF       
AP010/18/1977SCP       
AP010/24/1978SCS       
AP03/15/1980SCS       
AP03/23/1979SLR       
AP04/9/1979SCM       
AP05/31/1979SLR       
AP011/2/1979SLR       
AP07/20/1979SLR       
AP05/19/1980SLR       
AP04/20/1981SCM       
AP04/16/1981SCM       
AP03/26/1981SLR       
AP04/16/1981SCS       
AP08/24/1981SCP       
AP011/13/1981SLR       
AP011/12/1981SLR       
AP011/19/1981SCP       
AP08/5/1982SLR       
AP05/18/1982SCS       
AP010/27/1982SCM       
AP08/20/1982SCS       
AP010/29/1982SCS       
AP03/1/1983SCM       
AP04/6/1983SLR       
AP03/14/1983SLR       
AP03/14/1983SLR       
AP03/14/1983SLR       
AP03/29/1983SCS       
AP04/18/1983SCP       
AP06/26/1985SCS       
AP06/26/1985SCS       
AP05/31/1985SCM       
AP06/27/1985SLR       
AP08/6/1985SCM       
AP01/15/1986SCP       
AP06/16/1986SCP       
AP06/16/1986SCS       
AP010/29/1986SCS       
AP010/27/1987SCS       
AP04/23/1987SCS       
AP02/7/2002SLR2091079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf 2/7/2002
AP05/25/1993SCS       
AP02/7/2002SLR2094081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf 2/7/2002
AP011/5/1997SCM       
AP09/17/1997SCS       
AP09/4/1998SCS       




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