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FDA Drug Application 017598 by MONARCH PHARMS

Application Number017598
Application Type New Drug Application
Sponsor ApplicantMONARCH PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/31/1975N       
AP09/17/1975SLR       
AP09/17/1975SCS       
AP06/1/1976SLR       
AP012/27/1976SLR       
AP03/1/1978SES       
AP011/12/1976SCF       
AP010/11/1978SES       
AP08/26/1977SCP       
AP07/26/1979SLR       
AP012/18/1979SCS       
AP010/31/1980SLR       
AP01/13/1981SCP       
AP07/16/1981SCP       
AP03/22/1982SCP       
AP04/27/1982SLR       
AP011/1/1984SPD       
AP012/11/1984SCF       
AP08/11/1987SLR       
AP02/12/1986SCF       
AP011/9/1990SLR       
AP09/9/1988SLR       
AP03/19/1997SLR       
AP08/8/1988SCP       
AP03/19/1997SLR       
AP012/1/1992SCS       
AP06/15/1990SE1       
AP03/6/1991SCS       
AP03/6/1991SCS       
AP02/22/1993SCM       
AP01/7/1994SLR       
AP09/11/1996SLR       
AP03/19/1997SLR       
AP02/13/1997SLR       
AP02/17/2000SCM       
AP07/28/2005SLR12497039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017376s056,017598s039ltr.pdf 8/3/2005
AP07/28/2005SLR12508039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf 8/3/2005
AP03/11/2008SLR19449040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf 3/13/2008
AP03/11/2008SLR19455040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf 3/13/2008
AP09/10/2007SLR17840041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf 9/11/2007
AP09/10/2007SLR17946041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017376s059,017598s041ltr.pdf 9/25/2007




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