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FDA Drug Application 019860 by J AND J CONSUMER INC

Application Number019860
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
AP011/22/1989N       
AP07/25/1991SLR       
AP01/6/1992SCM       
AP011/23/1992SLR       
AP07/6/1993SCM       
AP03/22/1995SCF       
AP02/2/1995SCM       
AP02/2/1995SCS       
AP02/2/1995SCP       
AP08/15/1994SLR       
AP01/3/1994SCM       
AP02/6/1997SCM       
AP09/4/1998SCP       
AP011/24/1999SCM       
AP011/29/1999SCM       
AP05/11/2000SCM       
AP04/5/2001SLR5012018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19860S18ltr.pdf 4/11/2001
AP09/26/2000SCM       
AP06/16/2004SLR9397020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf 6/16/2004
AP06/16/2004SLR20380020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019860_S020_IMODIUM_CHEWABLE_TABLETS.pdf 7/31/2008
AP05/3/2012SLR32651029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019860s029ltr.pdf 5/8/2012
AP02/21/2013SCM       




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