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FDA Drug Application 018211 by ORTHO MCNEIL JANSSEN

Application Number018211
Application Type New Drug Application
Sponsor ApplicantORTHO MCNEIL JANSSEN
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
AP011/29/1979N       
AP05/22/1981SCS       
AP06/11/1986SLR       
AP08/8/1986SCM       
AP02/25/1988SLR       
AP03/19/1991SLR       
AP01/26/1996SCS       
AP04/4/1996SCS       
AP02/21/1997SCS       
AP02/20/1998SCS       
AP03/12/1999SCM       
AP08/8/2000SCP       
AP04/15/2003SE823310014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018211_s014&s016_DITROPAN TABLETS.pdf 9/14/2009
AP04/15/2003SE85322014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf 4/16/2003
AP011/6/2000SCS       
AP04/15/2003SE85691016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-033,18211se8-016,20897slr010ltr.pdf 5/29/2003
AP04/15/2003SE823311016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018211_s014&s016_DITROPAN TABLETS.pdf 9/14/2009
AP04/15/2003SE85321016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf 4/16/2003
AP02/6/2008SLR19081017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018211s017ltr.pdf 2/13/2008
AP02/6/2008SLR19116017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf 2/14/2008




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