Back to FDA Applications sponsored by JANSSEN PHARMS

FDA Drug Application 020897 by JANSSEN PHARMS

Application Number020897
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/16/1998N534000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20897ltr.pdf 12/16/1998
AP012/16/1998N535000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20897.cfm 12/16/1998
AP012/16/1998N536000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20897lbl.pdf 12/16/1998
AP06/9/1999SCM       
AP06/22/1999SCF16224002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020897_S002_DITROPAN_AP.pdf 4/11/2007
AP05/25/1999SCS       
AP06/30/1999SCM       
AP09/28/1999SCM       
AP07/20/1999SCM       
AP09/29/1999SCM       
AP04/17/2000SLR       
AP04/15/2003SE85323009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf 4/16/2003
AP04/15/2003SE85324010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf 4/16/2003
AP04/15/2003SE85692010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-033,18211se8-016,20897slr010ltr.pdf 5/29/2003
AP06/30/2004SE89649013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20897se8-013ltr.pdf 6/30/2004
AP06/30/2004SE89703013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20897se8-013_Ditropan_lbl.pdf 7/1/2004
AP02/6/2008SLR19117018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf 2/14/2008
AP02/6/2008SLR19480018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020897s018ltr.pdf 3/17/2008
AP07/13/2009SLR22986024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020897s024ltr.pdf 7/17/2009
AP07/13/2009SLR23044024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020897s024lbl.pdf 7/23/2009
AP09/13/2016SLR47063025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020897s025lbl.pdf 9/15/2016
AP06/28/2011SLR29374028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s028lbl.pdf 6/30/2011
AP06/28/2011SLR29392028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020897s028ltr.pdf 7/5/2011
AP012/15/2011SLR31086029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s029lbl.pdf 12/20/2011
AP012/15/2011SLR31096029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020897s029ltr.pdf 12/20/2011
AP03/23/2012SLR32195030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020897s030ltr.pdf 3/27/2012
AP03/23/2012SLR32221030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s030lbl.pdf 3/27/2012
AP011/13/2012SLR34379031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020897Orig1s031ltr.pdf 11/14/2012
AP011/13/2012SLR34399031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s031lbl.pdf 11/15/2012
AP08/1/2013SLR36695032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020897Orig1s032ltr.pdf 8/5/2013
AP08/1/2013SLR36758032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020897s032lbl.pdf 8/9/2013
AP02/27/2015SLR41970033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020897Orig1s033ltr.pdf 3/2/2015
AP02/27/2015SLR42017033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf 3/4/2015
AP08/16/2016SCM       
AP09/13/2016SLR47039035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020897Orig1s035ltr.pdf 9/15/2016
AP09/13/2016SLR47182035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020897s035lbl.pdf 9/28/2016




Back to FDA Applications sponsored by JANSSEN PHARMS