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FDA Drug Application 021437 by GD SEARLE LLC

Application Number021437
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
AP09/27/2002N1901000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21437ltr.pdf 9/27/2002
AP09/27/2002N1902000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21437lbl.pdf 9/27/2002
AP09/27/2002N9125000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-437_Inspra.cfm 6/7/2004
AP010/7/2003SE16765002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21437se1-002ltr.pdf 10/7/2003
AP010/7/2003SE16786002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21437se1-002_inspra_lbl.pdf 10/10/2003
AP010/7/2003SE110157002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-437s002_Inspra.cfm 9/9/2004
AP01/31/2008SE518993005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s005lbl.pdf 1/31/2008
AP01/31/2008SE519050005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021437s005ltr.pdf 2/4/2008
AP05/7/2008SLR19800006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021437s006ltr.pdf 5/9/2008
AP05/7/2008SLR19847006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s006lbl.pdf 5/19/2008
AP06/22/2012SLR32993009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437s009ltr.pdf 6/26/2012
AP06/22/2012SLR33026009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009lbl.pdf 6/26/2012
AP06/22/2012SLR33173009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437Orig1s009ltr.pdf 7/13/2012
AP06/22/2012SLR33181009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf 7/13/2012
AP17/9/2012SLR32993009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437s009ltr.pdf 6/26/2012
AP17/9/2012SLR33026009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009lbl.pdf 6/26/2012
AP17/9/2012SLR33173009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021437Orig1s009ltr.pdf 7/13/2012
AP17/9/2012SLR33181009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021437s009_2lbl.pdf 7/13/2012
AP04/15/2013SCM       
AP05/16/2013SLR36093011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021437Orig1s011ltr.pdf 5/21/2013
AP05/16/2013SLR36097011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021437s011lbl.pdf 5/21/2013
AP07/26/2013SCM       
AP05/4/2016SLR45867013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021437Orig1s013ltr.pdf 5/5/2016
AP05/4/2016SLR45874013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021437s013lbl.pdf 5/5/2016




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