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FDA Drug Application 020958 by J AND J CONSUMER INC

Application Number020958
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 combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2000N6662000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-958_Pepcid.cfm 9/25/2003
AP010/16/2000N744000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20958ltr.pdf 10/16/2000
AP010/16/2000N745000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20958lbl.pdf 10/16/2000
AP09/24/2001SCS       
AP011/6/2001SCF5484002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001//20958s2lbl.pdf 4/25/2003
AP011/6/2001SCF16797002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020958_S002_PEPCIDTOC.cfm 6/18/2007
AP011/22/2002SCS       
AP011/5/2003SLR6904007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20958slr007ltr.pdf 11/13/2003
AP010/27/2004SLR10479010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20325s017,20801s010,20902s007,20958s010ltr.pdf 10/29/2004
AP07/18/2005SLR12029012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020958s012ltr.pdf 7/21/2005
AP07/18/2005SLR12044012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020958s012lbl.pdf 7/21/2005
AP06/9/2006SLR14286013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020958s013LTR.pdf 6/12/2006
AP011/18/2008SCF21240015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020958s015ltr.pdf 11/18/2008
AP011/18/2008SCF32213015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020958Orig1s015.pdf 3/27/2012
AP04/1/2013SCM       
AP07/30/2013SLR36677018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020958Orig1s018ltr.pdf 8/1/2013
AP07/30/2013SLR37169018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020958Orig1s018lbl.pdf 9/19/2013
AP012/7/2013SCM       
AP03/20/2014SCM       
AP07/14/2015SCM       
AP06/8/2016SLR46318025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020958Orig1s025ltr.pdf 6/14/2016
AP06/8/2016SLR46322025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020958Orig1s025lbl.pdf 6/14/2016




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