Back to FDA Applications sponsored by MERCK SHARP DOHME

FDA Drug Application 021029 by MERCK SHARP DOHME

Application Number021029
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/11/1999N980000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21029ltr.pdf 8/11/1999
AP08/11/1999N981000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21029_Temodar.cfm 8/11/1999
AP08/11/1999N982000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21029lbl.pdf 8/11/1999
AP06/9/2000SCS       
AP05/18/2001SCS       
AP03/5/2002SCS       
AP01/18/2002SLR8340004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21029-S004_TEMODAR_review.pdf 4/14/2004
AP01/18/2002SLR4119004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21029s4ltr.pdf 1/18/2002
AP01/18/2002SLR4121004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021029-S004_TEMODAR_lbl.pdf 1/18/2002
AP03/11/2003SE84477005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21029se8-005_temodar_lbl.pdf 3/26/2003
AP03/11/2003SE84478005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21029se8-005ltr.pdf 3/26/2003
AP07/15/2004SLR9768006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029s006ltr.pdf 7/21/2004
AP06/29/2004SLR9650007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029slr007ltr.pdf 6/30/2004
AP03/15/2005SE111252008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021029s008lbl.pdf 3/15/2005
AP03/15/2005SE111259008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s008ltr.pdf 3/18/2005
AP03/30/2005SLR11338009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s009ltr.pdf 3/31/2005
AP04/22/2005SLR11527010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021029s010ltr.pdf 4/28/2005
AP03/31/2006SLR13887011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021029s008, s011ltr.pdf 4/7/2006
AP010/19/2006SCM15152012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf 10/23/2006
AP010/19/2006SCM15177012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021029s012ltr.pdf 10/23/2006
AP04/26/2010SLR25362018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021029s018lbl.pdf 4/28/2010
AP04/26/2010SLR25390018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021029s018,022277s001ltr.pdf 4/29/2010
AP02/4/2011SLR27788020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf 2/9/2011
AP06/3/2011SLR29039021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf 6/7/2011
AP06/3/2011SLR29074021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022277s005,021029s021ltr.pdf 6/9/2011
AP01/8/2013SCM34857022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021029s022lbl.pdf 1/9/2013
AP03/20/2014SCM       
AP010/10/2013SCM       
AP05/5/2014SLR39229026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021029Orig1s026ltr.pdf 5/6/2014
AP05/5/2014SLR39234026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021029s026lbl.pdf 5/6/2014
AP09/19/2014SCM       
AP04/2/2015SLR42418028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s028ltr.pdf 4/3/2015
AP04/2/2015SLR42460028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s028lbl.pdf 4/7/2015
AP09/18/2015SLR43934029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s029ltr.pdf 9/22/2015
AP09/18/2015SLR43955029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf 9/23/2015
AP02/12/2016SLR45174031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021029Orig1s031ltr.pdf 2/16/2016
AP02/12/2016SLR45200031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf 2/18/2016




Back to FDA Applications sponsored by MERCK SHARP DOHME