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FDA Drug Application 019487 by J AND J CONSUMER INC

Application Number019487
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 manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/1/1988N       
AP012/6/1988SCP       
AP01/5/1989SCM       
AP01/29/1990SCM       
AP02/9/1990SCM       
AP011/23/1992SE1       
AP05/13/1993SCF       
AP05/17/1991SCP       
AP07/16/1992SCP       
AP08/15/1994SLR       
AP02/12/1996SCP       
AP03/22/1996SLR       
AP010/28/1996SLR       
AP09/4/1998SCP       
AP012/3/1999SCM       
AP06/16/2004SLR9396021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487slr021,19860slr020,20606slr009,21140slr003ltr.pdf 6/16/2004
AP06/16/2004SLR19607021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019487_S021_IMODIUM A-D LIQUID.pdf 4/4/2008
AP07/8/2004SCF9737022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19487scf022ltr.pdf 7/14/2004
AP07/8/2004SCF20389022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019487_S022_IMODIUM_A-D LIQUID.pdf 7/31/2008
AP06/8/2005SCP11785023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019487s023ltr.pdf 6/9/2005
AP06/8/2005SCP20336023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019487_s023_IMODIUM A-D LIQUID.pdf 7/30/2008
AP03/18/2015SLR42215027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019487Orig1s027ltr.pdf 3/19/2015
AP03/18/2015SLR42249027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019487Orig1s027lbl.pdf 3/24/2015
AP04/5/2016SLR45600028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019487Orig1s028ltr.pdf 4/7/2016
AP04/5/2016SLR45639028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019487Orig1s028lbl.pdf 4/11/2016
AP05/17/2016SCM       




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