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FDA Drug Application 019766 by MERCK

Application Number019766
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1991N17206000Patent Request  http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_Zocor_Patent_Request.pdf 7/9/2007
AP012/23/1991N18960000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm 1/25/2008
AP011/27/1992SLR       
AP08/9/1993SCP       
AP02/22/1994SLR       
AP011/24/1993SCP       
AP02/22/1994SLR       
AP01/23/1995SLR       
AP07/28/1994SCM       
AP04/19/1995SLR19619008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s008_ZOCOR_TABLETS.pdf 4/4/2008
AP012/21/1994SLR       
AP02/16/1995SLR       
AP06/30/1995SE1       
AP08/1/1995SCS19620012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s012_ZOCOR_TABLETS.pdf 4/4/2008
AP011/6/1995SCS       
AP06/9/1995SLR19621014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s014_ZOCOR_TABLETS.pdf 4/4/2008
AP08/1/1995SLR       
AP011/22/1996SCS19201016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_S016_ZOCOR_TABLETS.pdf 2/19/2008
AP05/23/1997SLR       
AP05/19/1997SLR4358018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766a_s018.pdf 5/19/1997
AP03/17/1997SCS       
AP08/12/1997SLR       
AP010/31/1997SE1       
AP07/18/1997SCM19168022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S022_ZOCOR_TABLETS.pdf 2/19/2008
AP09/9/1997SCS19167023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S023_ZOCOR_TABLETS.pdf 2/19/2008
AP012/2/1997SCS19221025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S025_ZOCOR_TABLETS.pdf 2/19/2008
AP07/10/1998SE1522026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf 7/10/1998
AP07/10/1998SE1523026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.cfm 7/10/1998
AP03/31/1998SE1542027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s27ltr.pdf 3/31/1998
AP03/31/1998SE12107027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766s027_Zocor.cfm 3/31/1998
AP07/10/1998SE2560028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf 7/10/1998
AP07/10/1998SE2561028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.cfm 7/10/1998
AP06/29/1998SLR801029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766a_s029.pdf 6/29/1998
AP09/24/1998SCM19219030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766_S030_ZOCOR_TABLETS.pdf 2/19/2008
AP04/23/1999SLR19622031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s031_ZOCOR_TABLETS.pdf 4/4/2008
AP08/5/1999SE11082032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19766s32ltr.pdf 8/5/1999
AP03/22/1999SCE19220033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_S033_ZOCOR_TABLET.pdf 2/19/2008
AP011/22/1999SE11203034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf 11/22/1999
AP09/15/1999SLR19623035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s035_ZOCOR TABLETS.pdf 4/4/2008
AP011/22/1999SE11294036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf 11/22/1999
AP08/22/2000SLR       
AP04/27/2000SE21354040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19766S40LTR.PDF 4/27/2000
AP04/27/2000SE22113040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor.cfm 4/27/2000
AP04/27/2000SE25207040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor_prntlbl.pdf 4/27/2000
AP03/15/2000SCS20493041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_s041_ZOCOR_TABLETS.pdf 8/4/2008
AP011/7/2000SE8       
AP04/14/2000SCM18565043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S043_ZOCOR_TABLETS.pdf 11/19/2007
AP012/11/2000SCP18564044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S044_ZOCOR_TABLET.pdf 11/19/2007
AP011/14/2001SLR19178045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S045_ZOCOR.pdf 2/19/2008
AP04/10/2001SCM19180047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S047_ZOCOR.pdf 2/19/2008
AP04/10/2001SCM19181048   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S048_ZOCOR.pdf 2/19/2008
AP06/4/2001SCS19182049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S049_ZOCOR.pdf 2/19/2008
AP09/13/2001SCS19183050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S050_ZOCOR.pdf 2/19/2008
AP05/6/2002SLR2115051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s51ltr.pdf 5/6/2002
AP05/6/2002SLR2117051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s51lbl.pdf 5/6/2002
AP03/21/2002SE82118052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s52ltr.pdf 3/21/2002
AP03/21/2002SE82119052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766S52lbl.pdf 3/21/2002
AP03/21/2002SE82120052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-766s052_Zocor.cfm 3/21/2002
AP011/14/2001SLR5923053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf 6/16/2003
AP011/14/2001SLR19177053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S053_ZOCOR.pdf 2/19/2008
AP03/21/2002SCP19176054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S054_ZOCOR.pdf 2/19/2008
AP02/22/2002SCM19175055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S055_ZOCOR.pdf 2/19/2008
AP010/18/2002SE52122056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766se5-056ltr.pdf 10/18/2002
AP010/18/2002SE52125056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s56lbl.pdf 10/18/2002
AP05/6/2002SCS       
AP04/16/2003SE15361058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-058_zocor_lbl.pdf 4/17/2003
AP04/16/2003SE15703058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766se1-058ltr.pdf 5/29/2003
AP04/16/2003SE116194058   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019766_S058_ZOCOR_TABS_AP.pdf 4/9/2007
AP09/17/2003SLR6699065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf 9/29/2003
AP09/17/2003SLR6677065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf 9/25/2003
AP09/17/2003SLR6679066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf 9/25/2003
AP09/17/2003SLR6700066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf 9/29/2003
AP02/24/2004SLR7720067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf 2/25/2004
AP02/24/2004SLR8191067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf 4/5/2004
AP02/24/2004SLR16995067   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf 7/6/2007
AP02/25/2004S16996068   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf 7/6/2007
AP02/25/2004S8192068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf 4/5/2004
AP02/25/2004S7721068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf 2/25/2004
AP08/31/2005SLR12739069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf 9/8/2005
AP08/31/2005SLR12740069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s069ltr.pdf 9/8/2005
AP05/17/2005SLR11665070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s070ltr.pdf 5/20/2005
AP05/17/2005SLR11693070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s070lbl.pdf 5/20/2005
AP06/1/2007SCS16666074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s074ltr.pdf 6/4/2007
AP06/1/2007SCS16685074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf 6/4/2007
AP011/26/2007SLR18603075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s075ltr.pdf 12/3/2007
AP011/26/2007SLR18613075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf 12/3/2007
AP06/11/2008SLR20011076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019766s076ltr.pdf 6/13/2008
AP06/11/2008SLR20041076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf 6/19/2008
AP06/8/2011SLR29064077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf 6/8/2011
AP06/8/2011SLR29068077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf 6/8/2011
AP06/8/2011SLR29634077   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766s077.pdf 8/15/2011
AP03/2/2010SLR24880078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf 3/2/2010
AP03/2/2010SLR24997078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s078ltr.pdf 3/8/2010
AP06/10/2011SLR29224079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP04/8/2010SLR25256080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s080ltr.pdf 4/13/2010
AP04/8/2010SLR25304080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf 4/19/2010
AP011/4/2010SLR26900081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s081ltr.pdf 11/8/2010
AP011/4/2010SLR26912081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s081lbl.pdf 11/4/2010
AP06/8/2011SLR29063082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf 6/8/2011
AP06/8/2011SLR29069082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf 6/8/2011
AP010/6/2011SLR30240083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s083ltr.pdf 10/12/2011
AP010/6/2011SLR30254083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s083lbl.pdf 10/12/2011
AP010/6/2011SLR32836083   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766Orig1s083.pdf 6/6/2012
AP02/28/2012SLR31959085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766s085ltr.pdf 2/29/2012
AP02/28/2012SLR31978085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf 3/1/2012
AP011/15/2012SCM       
AP010/31/2012SLR34230087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf 11/2/2012
AP010/31/2012SLR34241087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf 11/5/2012
AP010/31/2012SLR34242088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf 11/5/2012
AP010/31/2012SLR34231088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf 11/2/2012
AP010/25/2013SLR37597090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019766Orig1s090ltr.pdf 10/28/2013
AP010/25/2013SLR37649090   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf 10/31/2013
AP02/27/2014SLR38632091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019766Orig1s091ltr.pdf 2/28/2014
AP02/27/2014SLR38652091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf 3/4/2014
AP02/2/2015SLR41764093   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019766Orig1s093ltr.pdf 2/3/2015
AP02/2/2015SLR41776093   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf 2/3/2015
AP03/1/2016SCM       




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