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FDA Drug Application 017376 by MONARCH PHARMS

Application Number017376
Application Type New Drug Application
Sponsor ApplicantMONARCH PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/30/1973N       
AP010/8/1974S       
AP05/1/1974S       
AP010/8/1974SLR       
AP05/15/1975SCS       
AP011/25/1974SCS       
AP02/12/1976SLR       
AP012/27/1976SLR       
AP03/7/1977SCF       
AP011/22/1976SCP       
AP011/22/1976SCP       
AP010/11/1978SES       
AP04/21/1977SCP       
AP07/5/1977SCP       
AP07/26/1979SES       
AP012/8/1978SCS       
AP011/20/1978SCP       
AP010/28/1980SCS       
AP09/9/1980SCE       
AP010/31/1980SLR       
AP01/9/1981SCP       
AP010/9/1981SCP       
AP011/3/1981SCS       
AP04/27/1982SLR       
AP011/1/1984SPD       
AP012/7/1982SCP       
AP03/25/1983SCP       
AP02/20/1985SCM       
AP01/16/1985SCM       
AP08/11/1987SLR       
AP08/9/1985SCS       
AP011/9/1990SLR       
AP02/2/1989SLR       
AP06/15/1990SE1       
AP03/19/1997SLR       
AP03/19/1997SLR       
AP012/1/1992SCS       
AP02/22/1993SCM       
AP01/7/1994SLR       
AP09/11/1996SLR       
AP03/19/1997SLR       
AP04/7/1998SLR       
AP02/12/1997SLR       
AP01/31/2000SCM       
AP010/4/2000SCP       
AP07/28/2005SLR12496056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017376s056,017598s039ltr.pdf 8/3/2005
AP07/28/2005SLR12507056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017376s056,017598s039lbl.pdf 8/3/2005
AP03/11/2008SLR19450058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017376s058,017598s040,018452s025lbl.pdf 3/13/2008
AP03/11/2008SLR19454058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017376s058, 017598s040, 018452s025ltr.pdf 3/13/2008
AP09/10/2007SLR17841059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017376s059,017598s041lbl.pdf 9/11/2007
AP09/10/2007SLR17945059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017376s059,017598s041ltr.pdf 9/25/2007
AP08/30/2013SLR36953060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017376Orig1s060ltr.pdf 9/5/2013
AP08/30/2013SLR37024060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017376s060lbl.pdf 9/9/2013




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