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FDA Drug Application 019268 by GD SEARLE LLC

Application Number019268
Application Type New Drug Application
Sponsor ApplicantGD SEARLE LLC
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
AP012/27/1988N12366000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111315.htm 7/29/2005
AP012/27/1988N31012000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019268Orig1s000.pdf 12/16/2011
AP02/8/1989SCM       
AP04/18/1989SCM       
AP06/27/1989SCP       
AP07/16/1990SCP       
AP05/9/1990SCS       
AP04/5/1990SLR       
AP06/21/1991SCM       
AP04/5/1990SLR       
AP09/21/1990SCF       
AP09/6/1990SLR       
AP04/23/1991SLR       
AP07/29/1991SLR       
AP010/28/1992SCP       
AP05/10/1993SCM       
AP05/31/1994SCP       
AP06/11/1996SCS       
AP08/13/1997SLR       
AP06/10/1996SCM       
AP04/10/1997SCS       
AP07/30/1997SCP       
AP07/14/1998SCS       
AP010/15/1998SCS       
AP010/15/1998SCS       
AP012/3/1998SCE       
AP06/22/2000SLR       
AP08/11/1999SCP       
AP01/7/2000SCS       
AP010/19/2000SCM       
AP010/19/2000SCS       
AP04/17/2002SLR2672037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19268s037ltr.pdf 4/17/2002
AP04/17/2002SLR2673037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf 4/17/2002
AP07/1/2002SCS       
AP08/13/2003SLR6485039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19268slr039ltr.pdf 8/14/2003
AP08/13/2003SLR6486040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19268slr040ltr.pdf 8/14/2003
AP09/11/2009SLR23534041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019268s041lbl.pdf 10/6/2009
AP09/11/2009SLR23848041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019268s041ltr.pdf 11/12/2009
AP011/19/2012SLR34436047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019268Orig1s047ltr.pdf 11/21/2012
AP011/19/2012SLR34457047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf 11/26/2012
AP02/8/2013SCM       




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