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FDA Drug Application 019898 by BRISTOL MYERS SQUIBB

Application Number019898
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
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
AP010/31/1991N       
AP03/18/1992SCM       
AP03/22/1993SLR       
AP03/22/1993SCS       
AP07/7/1992SCP       
AP07/23/1993SCS       
AP02/8/1994SLR       
AP02/9/1994SCF       
AP03/2/1994SLR       
AP03/30/1995SLR       
AP09/28/1994SLR       
AP04/30/1996SCS       
AP03/22/1996SE1       
AP02/28/1996SCS       
AP07/2/1996SE1       
AP04/4/1996SCS18563016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019898_S016_PRAVACOL_TABLETS.pdf 11/19/2007
AP04/15/1997SLR4321017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019898a_s017_041597.pdf 4/15/1997
AP03/27/1998SE1398018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19898-S018_Pravachol.pdf 3/27/1998
AP05/20/1998SLR       
AP03/11/1998SE1587020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19898-S020_Pravachol.pdf 3/11/1998
AP08/17/1998SLR       
AP010/26/1998SCP       
AP02/11/1999SCM19171023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S023_PRAVACHOL_TABLETS.pdf 2/19/2008
AP01/28/1999SCM19172024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S024_PRAVACHOL_TABLETS.pdf 2/19/2008
AP04/9/1999SCS19173025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_S025_PRAVACHOL_TABLETS.pdf 2/19/2008
AP01/18/2000SE11255026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF 1/18/2000
AP01/18/2000SE11261027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF 1/18/2000
AP01/18/2000SE21262029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF 1/18/2000
AP01/18/2000SE21263030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S26LTR.PDF 1/18/2000
AP06/9/2000SE11264031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19898S31LTR.PDF 6/9/2000
AP06/9/2000SE116212031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_S031_PRAVACHOL_TABLETS_AP.pdf 4/11/2007
AP02/10/2000SE13584032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898s032_Pravastatin.cfm 2/10/2000
AP02/10/2000SE11277032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/19898S32LTR.PDF 2/10/2000
AP010/14/1999SE11323034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19898s34ltr.PDF 10/14/1999
AP010/14/1999SE11324034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.pdf 10/14/1999
AP010/14/1999SCM1336035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19898s34ltr.PDF 10/14/1999
AP010/14/1999SCM1337035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898S34.PDF 10/14/1999
AP010/14/1999SCM1338035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19898s34_Pravachol.pdf 10/14/1999
AP09/13/1999SLR20532036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019898_s036_PRAVACHOL_TABLETS.pdf 8/8/2008
AP06/23/2000SE820491037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_s037_PRAVACHOL_TABLETS.pdf 8/4/2008
AP08/24/2000SCF20490041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019898_s041_PRAVACHOL_TABLETS.pdf 8/4/2008
AP06/15/2001SE83582042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19898S42ltr.pdf 6/15/2001
AP06/15/2001SE83583042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s42lbl.pdf 6/15/2001
AP03/12/2001SCM20471043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019898_s043_PRAVACHOL TABS.pdf 8/4/2008
AP03/14/2001SCS20470044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019898_s044_PRAVACHOL TABS.pdf 8/4/2008
AP08/13/2001SCM       
AP012/18/2001SE23677046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898s46ltr.pdf 12/18/2001
AP012/18/2001SE23678046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19898s46lbl.pdf 12/18/2001
AP01/14/2002SCM18562049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_S049_PRAVACOL_TABLETS.pdf 11/19/2007
AP07/12/2002SLR20445050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_s050_PRAVACHOL TABS.pdf 8/4/2008
AP07/12/2002SLR3580050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898slr050ltr.pdf 7/12/2002
AP07/12/2002SLR3581050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s50lbl.pdf 7/12/2002
AP06/14/2002SCS18561051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019898_S051_PRAVACOL_TABLETS.pdf 11/19/2007
AP010/29/2002SE53578052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19898se5-052ltr.pdf 10/29/2002
AP010/29/2002SE53579052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s052lbl.pdf 10/29/2002
AP09/5/2003SLR6648054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19898slr054ltr.pdf 9/25/2003
AP09/5/2003SLR6683054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19898slr054_pravachol_lbl.pdf 9/25/2003
AP09/5/2003SLR20398054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019898_s054_PRAVACHOL TABS.pdf 8/1/2008
AP07/6/2005SLR11987058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019898s058lbl.pdf 7/15/2005
AP07/6/2005SLR11993058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019898s058ltr.pdf 7/15/2005
AP02/28/2007SE815981060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019898s060ltr.pdf 3/7/2007
AP02/28/2007SE815995060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019898s060lbl.pdf 3/7/2007
AP05/18/2011SLR28873061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019898s061ltr.pdf 5/20/2011
AP05/18/2011SLR28898061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019898s061lbl.pdf 5/23/2011
AP05/18/2011SLR36720061   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019898Orig1s061.pdf 8/7/2013
AP02/28/2012SLR31941062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898s062ltr.pdf 2/28/2012
AP02/28/2012SLR31947062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062lbl.pdf 2/28/2012
AP02/28/2012SLR31948062Tracked Changes Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062-trackedchangeslbl.pdf 2/28/2012
AP02/28/2012SLR32304062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019898s062.pdf 3/30/2012
AP010/31/2012SLR34246063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898Orig1s063,s064ltr.pdf 11/5/2012
AP010/31/2012SLR34312063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf 11/6/2012
AP010/31/2012SLR34313064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s063s064lbl.pdf 11/6/2012
AP010/31/2012SLR34247064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019898Orig1s063,s064ltr.pdf 11/5/2012
AP05/29/2013SCM       
AP07/5/2016SLR46470066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019898Orig1s066ltr.pdf 7/7/2016
AP07/5/2016SLR46477066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019898s066lbl.pdf 7/8/2016




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