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FDA Drug Application 020903 by MERCK SHARP DOHME

Application Number020903
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/3/1998N696000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903ltr.pdf 6/3/1998
AP06/3/1998N697000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903lbl.pdf 6/3/1998
AP06/3/1998N6456000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020903_rebetol_toc.cfm 8/8/2003
AP06/3/1998N15844000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089017.pdf 2/20/2007
AP012/9/1998SE5939001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903s1ltr.pdf 12/9/1998
AP012/9/1998SE5940001   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf 12/9/1998
AP012/9/1998SLR1048002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20903s1ltr.pdf 12/9/1998
AP012/9/1998SLR1049002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20903s1lbl.pdf 12/9/1998
AP03/2/2000SCP       
AP012/18/2000SLR       
AP02/23/2001SLR5467005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s5lbl.pdf 4/25/2003
AP03/13/2001SLR1570006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s7ltr.pdf 3/13/2001
AP03/13/2001SLR9050006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903S006S007_Rebetol.pdf 6/4/2004
AP03/13/2001SLR1594007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s7ltr.pdf 3/13/2001
AP03/13/2001SLR9051007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903S006S007_Rebetol.pdf 6/4/2004
AP07/25/2001SLR3100008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf 7/26/2001
AP07/25/2001SLR3101008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf 7/26/2001
AP07/25/2001SLR11424008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm 4/15/2005
AP010/31/2001SLR5464010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s10lbl.pdf 4/25/2003
AP07/25/2001SLR3102011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf 7/26/2001
AP07/25/2001SLR3103011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf 7/26/2001
AP07/25/2001SLR11425011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm 4/15/2005
AP07/25/2001SLR3104012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf 7/26/2001
AP07/25/2001SLR3105012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf 7/26/2001
AP07/25/2001SLR11426012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm 4/15/2005
AP012/28/2001SE81811013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s13ltr.pdf 12/28/2001
AP012/28/2001SE85465013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s13lbl.pdf 4/25/2003
AP010/24/2001SLR5466014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s14lbl.pdf 4/25/2003
AP02/21/2002SLR1812015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903s15ltr.pdf 2/21/2002
AP07/25/2001SLR3106016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20903s8s11s12s16ltr.pdf 7/26/2001
AP07/25/2001SLR3107016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20903s8s11s12s16lbl.pdf 7/26/2001
AP07/25/2001SLR11427016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-903s008s011s012s016_Rebetol.cfm 4/15/2005
AP011/5/2001SCS       
AP08/29/2001SCS       
AP03/6/2002SLR1810020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903s20ltr.pdf 3/6/2002
AP03/6/2002SLR11423020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-903s020_Rebetol.cfm 4/15/2005
AP01/3/2002SCS       
AP09/3/2002SLR1809023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903s23lbl.pdf 9/3/2002
AP09/3/2002SLR1912023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903slr023ltr.pdf 9/3/2002
AP011/13/2002SLR       
AP011/13/2002SLR1911025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903slr025_Rebetron_lbl.pdf 11/13/2002
AP011/13/2002SLR6285025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20903slr025ltr.pdf 7/31/2003
AP011/13/2002SLR7271025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20903slr025_Rebetron_medguide.pdf 12/17/2003
AP012/20/2002SCS       
AP06/9/2003SLR5964028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr028ltr.pdf 6/22/2003
AP06/9/2003SLR5996028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr028_rebetol_lbl.pdf 6/22/2003
AP05/21/2003SLR5837029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr029ltr.pdf 6/8/2003
AP05/21/2003SLR5889029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr029_rebetol_lbl.pdf 6/8/2003
AP07/9/2003SLR6119030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903s30lbl_Rebetol.pdf 7/9/2003
AP07/9/2003SLR9358030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr030ltr.pdf 6/14/2004
AP07/9/2003SLR20407030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020903_S30_REBETOL REBETRON.pdf 8/1/2008
AP010/10/2003SLR6799032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20903slr032ltr.pdf 10/16/2003
AP010/10/2003SLR6800032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20903slr032_rebetol_lbl.pdf 10/16/2003
AP010/10/2003SLR20408032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020903_S32_REBETOL RETETRON.pdf 8/1/2008
AP06/8/2004SLR9308033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20903slr033ltr.pdf 6/10/2004
AP06/8/2004SLR9317033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr033_rebetron_lbl.pdf 6/10/2004
AP06/24/2004SLR9530034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20903slr034ltr.pdf 6/24/2004
AP06/24/2004SLR9534034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20903slr034_rebetol_lbl.pdf 6/24/2004
AP08/25/2006SLR14757038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020903s038lbl.pdf 8/29/2006
AP08/25/2006SLR14868038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020903s038ltr.pdf 9/18/2006
AP04/13/2007SLR16239039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020903s039ltr.pdf 4/20/2007
AP04/13/2007SLR16273039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s039lbl.pdf 4/20/2007
AP012/4/2007SLR18662040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020903s040lbl.pdf 12/14/2007
AP012/4/2007SLR18862040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020903s040ltr.pdf 1/9/2008
AP011/6/2009SLR23903042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf 11/16/2009
AP011/6/2009SLR24555042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf 1/20/2010
AP011/6/2009SLR23904043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf 11/16/2009
AP011/6/2009SLR24556043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf 1/20/2010
AP011/6/2009SLR23905044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf 11/16/2009
AP011/6/2009SLR24557044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf 1/20/2010
AP011/6/2009SLR23906045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf 11/16/2009
AP011/6/2009SLR24558045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf 1/20/2010
AP010/28/2010SLR26831046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf 10/29/2010
AP010/28/2010SLR26832046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002MedGuide.pdf 10/29/2010
AP010/28/2010SLR26881046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020903s046,021546s002ltr.pdf 11/3/2010
AP05/6/2011SLR28772048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020903s048,021546s004ltr.pdf 5/10/2011
AP01/4/2013SCM       
AP02/6/2013SLR35101050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s050,021546Orig1s006ltr.pdf 2/8/2013
AP02/6/2013SLR35105050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s050,021546s006lbl.pdf 2/8/2013
AP05/31/2013SLR36199051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s051,021546Orig1s007ltr.pdf 6/4/2013
AP05/31/2013SLR36210051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf 6/4/2013
AP011/15/2013SLR37843052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s052,021546Orig1s008ltr.pdf 11/18/2013
AP011/15/2013SLR37899052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf 11/22/2013
AP05/21/2015SLR42882053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020903Orig1s053,021546Orig1s009ltr.pdf 5/22/2015
AP05/21/2015SLR42912053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020903s053,021546s009lbl.pdf 5/27/2015




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