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FDA Drug Application 019886 by GD SEARLE LLC

Application Number019886
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/13/1990N       
AP03/16/1990SCS       
AP01/18/1991SLR       
AP03/25/1991SCP       
AP03/28/1991SLR       
AP08/1/1991SCM       
AP08/28/1991SLR       
AP010/26/1994SLR       
AP09/29/1995SCM       
AP012/7/1995SLR       
AP012/24/1998SE8717013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19886s13ltr.pdf 12/24/1998
AP012/24/1998SE8718013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019886S013%20.cfm 7/21/1999
AP04/22/1999SCM       
AP05/6/1999SCM       
AP03/29/2001SCP       
AP02/6/2001SCM       
AP01/24/2001SCE       
AP06/28/2002SCS       
AP04/12/2006SLR13923022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019886s022lbl.pdf 4/13/2006
AP04/12/2006SLR13929022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019886s022ltr.pdf 4/13/2006
AP01/4/2011SLR27470026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019886s026,s027ltr.pdf 1/7/2011
AP01/4/2011SLR27509026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf 1/11/2011
AP01/4/2011SLR27510027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf 1/11/2011
AP01/4/2011SLR27471027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019886s026,s027ltr.pdf 1/7/2011
AP01/11/2012SLR31385030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019886s030lbl.pdf 1/12/2012
AP01/11/2012SLR31389030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019886s030ltr.pdf 1/17/2012
AP03/25/2014SCM       
AP08/8/2015SLR43610032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019886s032lbl.pdf 8/10/2015
AP08/8/2015SLR43614032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019886Orig1s032ltr.pdf 8/11/2015




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