Back to FDA Applications sponsored by MERCK

FDA Drug Application 019510 by MERCK

Application Number019510
Application Type New Drug Application
Sponsor ApplicantMERCK
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
AP011/4/1986N5522000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19510lbl.pdf 4/30/2003
AP012/12/1986SLR       
AP04/1/1987SLR       
AP06/3/1987SCS       
AP011/23/1988SLR       
AP01/7/1992SCM       
AP010/28/1988SLR       
AP011/30/1990SLR       
AP011/30/1990SLR       
AP06/29/1995SLR       
AP012/10/1991SLR       
AP05/16/1997SLR       
AP011/30/1990SLR       
AP05/8/1996SCP       
AP06/29/1995SLR       
AP06/29/1995SLR       
AP06/29/1995SLR       
AP01/30/1996SCP       
AP08/12/1998SLR       
AP05/6/1999SCS       
AP05/16/1997SLR       
AP011/12/1997SLR       
AP012/19/1997SCS       
AP01/28/1999SLR       
AP03/18/1999SLR1208026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019510S026_pepcid.pdf 3/18/1999
AP04/25/2001SLR       
AP06/6/2002SE83370028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19510s028ltr.pdf 6/6/2002
AP06/6/2002SE83371028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19510s28lbl20249s11lbl.pdf 6/6/2002
AP06/6/2002SE821571028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019510_s028_Pepcid Injection.pdf 1/12/2009
AP03/14/2001SLR1608029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20249S12LTR.PDF 3/14/2001
AP03/14/2001SLR1609029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20249S12LBL.PDF 3/14/2001
AP08/1/2002SCP       
AP011/5/2007SLR18341031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf 11/7/2007
AP011/5/2007SLR18354031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf 11/8/2007




Back to FDA Applications sponsored by MERCK