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FDA Drug Application 018841 by GD SEARLE

Application Number018841
Application Type New Drug Application
Sponsor ApplicantGD SEARLE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/29/1992N       
AP04/2/1993SLR       
AP012/27/1993SLR       
AP011/3/1995SCS       
AP02/22/1995SLR       
AP04/6/1995SLR       
AP09/10/1996SCS       
AP01/6/1998SLR       
AP06/13/1996SCS       
AP01/6/1998SLR       
AP06/11/1996SCM       
AP05/8/1997SCS       
AP01/25/2002SLR1646012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18841s12s16ltr.pdf 1/25/2002
AP01/25/2002SLR1647012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf 1/25/2002
AP01/6/1998SLR       
AP01/6/1998SLR       
AP01/25/2002SE51648016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18841s12s16ltr.pdf 1/25/2002
AP01/25/2002SE51649016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf 1/25/2002
AP02/22/2000SCM       
AP09/8/2000SCE       
AP04/10/2003SLR5360020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18841slr020_Daypro_lbl.pdf 4/17/2003
AP04/10/2003SLR8883020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18841slr020ltr.pdf 6/2/2004
AP01/18/2006SLR13427021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018841s021lbl.pdf 1/20/2006
AP01/18/2006SLR13467021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018841s021ltr.pdf 1/20/2006
AP06/21/2007SLR16904022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018841s022ltr.pdf 7/5/2007
AP06/21/2007SLR39243022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/18841s022lbl.pdf 5/7/2014
AP05/9/2016SLR45941028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf 5/11/2016
AP05/9/2016SLR46000028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018841Orig1s028ltr.pdf 5/12/2016
AP05/9/2016SLR46047028   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501638.pdf 5/18/2016




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