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FDA Drug Application 020249 by MERCK SHARP DOHME

Application Number020249
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP02/18/1994N       
AP06/29/1995SLR       
AP06/29/1995SLR       
AP06/26/1996SCS       
AP03/3/1997SCP       
AP05/31/1996SLR       
AP08/19/1998SCM       
AP08/12/1998SLR       
AP011/12/1997SLR       
AP03/18/1999SLR3372009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019510S026_pepcid.pdf 3/18/1999
AP04/25/2001SLR       
AP06/6/2002SE83368011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19510s028ltr.pdf 6/6/2002
AP06/6/2002SE83369011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf 6/6/2002
AP06/6/2002SE821620011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020249_s011_PEPCID INJECTION.pdf 1/12/2009
AP03/14/2001SLR3366012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20249S12LTR.PDF 3/14/2001
AP03/14/2001SLR3367012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF 3/14/2001
AP011/5/2007SLR18342013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf 11/7/2007
AP011/5/2007SLR18353013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf 11/8/2007




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