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FDA Drug Application 018343 by PAR PHARM

Application Number018343
Application Type New Drug Application
Sponsor ApplicantPAR PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/6/1981N14271000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP06/12/1981SCP       
AP010/7/1982SCS       
AP010/27/1981SCS       
AP011/30/1981SCF       
AP010/25/1982SES       
AP02/25/1982SCS       
AP03/9/1982SCS       
AP02/7/1984SCM       
AP07/10/1985SLR       
AP05/18/1983SCS       
AP010/14/1983SCF       
AP02/7/1984SCE       
AP010/14/1983SCP       
AP08/28/1984SES       
AP06/8/1984SCP       
AP06/8/1984SCP       
AP09/18/1984SCS       
AP01/17/1985SES       
AP07/12/1984SCP       
AP010/12/1984SLR       
AP011/19/1984SCS       
AP04/16/1985SCS       
AP06/12/1985SCM       
AP04/16/1985SCS       
AP012/18/1985SCP       
AP01/17/1986SLR       
AP02/27/1986SCE       
AP05/27/1986SCS       
AP09/17/1986SCS       
AP03/4/1986SCS       
AP03/23/1990SCS       
AP07/24/1986SCS       
AP08/14/1986SCM       
AP04/2/1987SCM       
AP02/13/1987SCS       
AP01/21/1987SCS       
AP01/6/1987SCP       
AP05/13/1988SE1       
AP06/26/1987SCE       
AP02/19/1988SLR       
AP05/13/1988SCS       
AP010/19/1989SLR       
AP05/3/1989SLR       
AP09/23/1993SE1       
AP05/10/1990SCM       
AP09/27/1990SLR       
AP03/21/1991SLR       
AP011/5/1990SCP       
AP04/12/1991SCM       
AP01/31/1991SCP       
AP010/7/1991SCM       
AP05/7/1992SCF       
AP06/19/1995SCS       
AP01/14/1992SCS       
AP012/21/1992SCS       
AP09/3/1992SLR       
AP06/25/1992SLR       
AP05/12/1993SCP       
AP03/31/1994SLR       
AP01/28/1994SE1       
AP011/4/1993SLR       
AP06/13/1995SCF       
AP03/6/1995SCS       
AP07/31/1996SLR       
AP03/1/1996SCS       
AP06/25/1996SCM       
AP08/21/1997SCS       
AP01/9/1998SCS       
AP04/20/1999SLR       
AP05/7/2004SLR8558075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18343slr075ltr.pdf 5/7/2004
AP09/25/2008SLR20897081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018343s081ltr.pdf 9/29/2008
AP05/19/2011SLR28885082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s082lbl.pdf 5/23/2011
AP05/19/2011SLR28921082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018343s082ltr.pdf 5/24/2011
AP012/14/2011SLR30985083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018343s083lbl.pdf 12/14/2011
AP012/14/2011SLR30997083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018343s083ltr.pdf 12/15/2011
AP08/27/2012SLR33573084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018343s084lbl.pdf 8/28/2012
AP08/27/2012SLR33580084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018343Orig1s084ltr.pdf 8/29/2012
AP012/24/2014SLR41438085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018343Orig1s085ltr.pdf 12/30/2014
AP012/24/2014SLR41599085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018343s085lbl.pdf 1/9/2015
AP06/19/2015SLR43095086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018343Orig1s086ltr.pdf 6/22/2015
AP06/19/2015SLR43101086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf 6/22/2015




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