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FDA Drug Application 021140 by J AND J CONSUMER INC

Application Number021140
Application Type New Drug Application
Sponsor ApplicantJ AND J CONSUMER INC
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
AP011/30/2000N1884000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium_Approv.pdf 11/29/2000
AP011/30/2000N1885000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium_prntlbl.pdf 11/29/2000
AP011/30/2000N1886000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-140_Imodium.cfm 1/29/2000
AP09/12/2001SCS       
AP01/27/2003SLR9102002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21140slr002ltr.pdf 6/7/2004
AP01/27/2003SLR9104002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21140slr002_imodium_lbl.pdf 6/7/2004
AP06/16/2004SLR9402003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf 6/16/2004
AP06/16/2004SLR20361003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021140_S003_IMODIUM_ADVANCED_CAPLETS.pdf 7/31/2008
AP04/30/2008SE819761011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020606se8-014, 021140se8-011ltr.pdf 5/5/2008
AP04/30/2008SE820216011   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020606se8-014, 021140se8-011_SUMR.pdf 7/16/2008
AP09/14/2007SCF17893012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021140s012lbl.pdf 9/19/2007
AP09/14/2007SCF17969012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021140s012ltr.pdf 9/25/2007
AP02/5/2008SLR19068013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021140s013ltr.pdf 2/7/2008
AP05/3/2012SLR32650016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021140s016ltr.pdf 5/8/2012
AP08/7/2015SCM       
AP03/18/2015SLR42214020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021140Orig1s020ltr.pdf 3/19/2015
AP03/18/2015SLR42248020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021140Orig1s020lbl.pdf 3/24/2015
AP02/3/2015SCM       
AP08/3/2015SCM       
AP09/1/2015SCM       
AP012/2/2015SCM       




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