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FDA Drug Application 021227 by MERCK

Application Number021227
Application Type New Drug Application
Sponsor ApplicantMERCK
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
AP01/26/2001N2299000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas.cfm 1/26/2001
AP01/26/2001N4543000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas_Approv.pdf 1/26/2001
AP01/26/2001N4544000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21227_Cancidas_prntlbl.pdf 1/26/2001
AP09/20/2002SE12295001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227se1-001,slr003ltr.pdf 9/20/2002
AP09/20/2002SE12296001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf 9/20/2002
AP09/20/2002SLR2297003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227se1-001,slr003ltr.pdf 9/20/2002
AP09/20/2002SLR2298003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227s1s3lbl.pdf 9/20/2002
AP04/11/2002SCS       
AP011/21/2002SLR2293005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21227slr005ltr.pdf 11/21/2002
AP011/21/2002SLR2294005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21227_cancidas_lbl.pdf 11/21/2002
AP06/12/2002SCM       
AP01/7/2003SE14212007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021227s007lbl.pdf 3/7/2003
AP01/7/2003SE18805007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21227se1-007ltr.pdf 5/28/2004
AP011/15/2002SCP       
AP012/10/2002SCS       
AP03/17/2004SLR8004011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227slr011,014ltr.pdf 3/24/2004
AP03/17/2004SLR8230011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_lbl.pdf 4/5/2004
AP09/29/2004SE110351012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227s012ltr.pdf 10/4/2004
AP09/29/2004SE110352012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227s012lbl.pdf 10/4/2004
AP03/17/2004SLR8005014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21227slr011,014ltr.pdf 3/24/2004
AP03/17/2004SLR8231014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21227slr011,014_cancidas_lbl.pdf 4/5/2004
AP03/17/2004SLR20359014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021227_S014_CANCIDAS.pdf 7/31/2008
AP02/16/2005SE811122015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21227s015ltr.pdf 2/17/2005
AP02/16/2005SE811137015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21227s015lbl.pdf 2/17/2005
AP07/29/2008SE520341021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021227s021ltr.pdf 7/31/2008
AP07/29/2008SE520611021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021227s021lbl.pdf 8/13/2008
AP07/21/2008SLR20292022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021227s022ltr.pdf 7/24/2008
AP06/26/2009SE822841023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021227s023lbl.pdf 6/29/2009
AP06/26/2009SE822857023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021227s023ltr.pdf 6/30/2009
AP05/4/2009SLR22455024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021227s024ltr.pdf 5/7/2009
AP01/28/2010SLR24709027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s027lbl.pdf 2/4/2010
AP01/28/2010SLR24729027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021227s027ltr.pdf 2/5/2010
AP010/22/2010SLR26769028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021227s028lbl.pdf 10/25/2010
AP010/22/2010SLR26858028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021227s028ltr.pdf 11/2/2010
AP04/30/2012N32595029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021227s029ltr.pdf 5/2/2012
AP08/2/2013SLR36694030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021227Orig1s030ltr.pdf 8/5/2013
AP08/2/2013SLR36708030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s030lbl.pdf 8/6/2013
AP01/8/2013SLR34859031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021227Orig1s031ltr.pdf 1/10/2013
AP01/8/2013SLR34875031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021227s031lbl.pdf 1/11/2013
AP012/18/2013SCM       
AP010/23/2014SLR40879033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021227Orig1s033ltr.pdf 10/27/2014
AP010/23/2014SLR41018033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021227s033lbl.pdf 11/18/2014
AP04/12/2016SLR45670034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf 4/13/2016
AP04/12/2016SLR45678034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021227Orig1s034,s035ltr.pdf 4/14/2016
AP04/12/2016SLR45671035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021227s034s035lbl.pdf 4/13/2016
AP04/12/2016SLR45679035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021227Orig1s034,s035ltr.pdf 4/14/2016




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