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FDA Drug Application 020325 by J AND J CONSUMER INC

Application Number020325
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
AP04/28/1995N       
AP05/31/1996SCS       
AP010/2/1995SCM       
AP05/3/1996SCP4651003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s3ltr.pdf 3/1/2002
AP04/23/1996SCM       
AP09/26/1997SCP       
AP011/9/1998SE2       
AP04/15/1998SCP       
AP011/5/1998SCS       
AP02/10/2000SCM       
AP04/5/2000SCP       
AP03/1/2002SLR3345013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20325s13ltr.pdf 3/1/2002
AP09/23/2003SE26709015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20325se2-015ltr.pdf 9/30/2003
AP09/23/2003SE26710015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-015_pepcid_lbl.pdf 9/30/2003
AP09/23/2003SE216654015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020325s015TOC.cfm 5/29/2007
AP010/27/2004SLR10476017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf 10/29/2004
AP06/9/2006SLR14284019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020325s019LTR.pdf 6/12/2006
AP010/11/2012SLR45643024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf 4/11/2016
AP04/1/2013SCM       
AP04/20/2015SCM       
AP05/6/2015SCM       
AP07/9/2015SCM       
AP05/5/2016SCM       
AP06/8/2016SLR46279030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020325Orig1s030ltr.pdf 6/9/2016
AP06/8/2016SLR46302030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf 6/13/2016
AP08/1/2016SCM       




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