BRISTOL MYERS SQUIBB FDA Approval NDA 019898

NDA 019898

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #019898

Documents

Letter2000-01-18
Letter2000-01-18
Letter2000-01-18
Letter2000-02-10
Letter1999-10-14
Letter1999-10-14
Letter2002-10-29
Letter2016-07-07
Label2002-07-12
Label2003-09-25
Label2005-07-15
Label2007-03-07
Label2011-05-23
Label2012-02-28
Label2016-07-08
Letter2000-01-18
Letter2000-06-09
Letter2001-06-15
Letter2001-12-18
Letter2002-07-12
Letter2003-09-25
Letter2005-07-15
Letter2007-03-07
Letter2011-05-20
Letter2012-02-28
Letter2012-11-05
Letter2012-11-05
Review1998-03-11
Review2008-02-19
Review2008-02-19
Review1999-10-14
Review2008-08-04
Review2008-08-04
Review2008-08-04
Review2013-08-07
Review2012-03-30
Label2001-06-15
Label2001-12-18
Label2002-10-29
Label2012-11-06
Label2012-11-06
Review2007-11-19
Review1997-04-15
Review1998-03-27
Review2008-02-19
Review2007-04-11
Review2000-02-10
Review1999-10-14
Review1999-10-14
Review2008-08-08
Review2008-08-04
Review2008-08-04
Review2007-11-19
Review2007-11-19
Review2008-08-01
Letter2020-09-28
Label2020-09-29
Letter2022-06-01
Label2022-06-06

Application Sponsors

NDA 019898BRISTOL MYERS SQUIBB

Marketing Status

Discontinued002
Prescription003
Prescription004
Prescription008

Application Products

002TABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1PRAVACHOLPRAVASTATIN SODIUM
003TABLET;ORAL20MG1PRAVACHOLPRAVASTATIN SODIUM
004TABLET;ORAL40MG1PRAVACHOLPRAVASTATIN SODIUM
008TABLET;ORAL80MG1PRAVACHOLPRAVASTATIN SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1991-10-31STANDARD
LABELING; LabelingSUPPL3AP1993-03-22
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1993-03-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1992-07-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-07-23STANDARD
LABELING; LabelingSUPPL7AP1994-02-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1994-02-09STANDARD
LABELING; LabelingSUPPL9AP1994-03-02STANDARD
LABELING; LabelingSUPPL10AP1995-03-30STANDARD
LABELING; LabelingSUPPL11AP1994-09-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1996-04-30STANDARD
EFFICACY; EfficacySUPPL13AP1996-03-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1996-02-28STANDARD
EFFICACY; EfficacySUPPL15AP1996-07-02UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1996-04-04STANDARD
LABELING; LabelingSUPPL17AP1997-04-15STANDARD
EFFICACY; EfficacySUPPL18AP1998-03-27UNKNOWN
LABELING; LabelingSUPPL19AP1998-05-20STANDARD
EFFICACY; EfficacySUPPL20AP1998-03-11STANDARD
LABELING; LabelingSUPPL21AP1998-08-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1998-10-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1999-02-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1999-01-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1999-04-09STANDARD
EFFICACY; EfficacySUPPL26AP2000-01-18STANDARD
EFFICACY; EfficacySUPPL27AP2000-01-18STANDARD
EFFICACY; EfficacySUPPL29AP2000-01-18STANDARD
EFFICACY; EfficacySUPPL30AP2000-01-18STANDARD
EFFICACY; EfficacySUPPL31AP2000-06-09STANDARD
EFFICACY; EfficacySUPPL32AP2000-02-10UNKNOWN
EFFICACY; EfficacySUPPL34AP1999-10-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP1999-10-14STANDARD
LABELING; LabelingSUPPL36AP1999-09-13STANDARD
EFFICACY; EfficacySUPPL37AP2000-06-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2000-08-24STANDARD
EFFICACY; EfficacySUPPL42AP2001-06-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL43AP2001-03-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL44AP2001-03-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL45AP2001-08-13STANDARD
EFFICACY; EfficacySUPPL46AP2001-12-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL49AP2002-01-14STANDARD
LABELING; LabelingSUPPL50AP2002-07-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL51AP2002-06-14STANDARD
EFFICACY; EfficacySUPPL52AP2002-10-29PRIORITY
LABELING; LabelingSUPPL54AP2003-09-05STANDARD
LABELING; LabelingSUPPL58AP2005-07-06STANDARD
EFFICACY; EfficacySUPPL60AP2007-02-28UNKNOWN
LABELING; LabelingSUPPL61AP2011-05-18STANDARD
LABELING; LabelingSUPPL62AP2012-02-28UNKNOWN
LABELING; LabelingSUPPL63AP2012-10-31901 REQUIRED
LABELING; LabelingSUPPL64AP2012-10-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL65AP2013-05-29STANDARD
LABELING; LabelingSUPPL66AP2016-07-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL67AP2017-01-23STANDARD
LABELING; LabelingSUPPL69AP2020-09-25901 REQUIRED
LABELING; LabelingSUPPL70AP2022-05-31STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL12Null0
SUPPL14Null0
SUPPL16Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL35Null0
SUPPL41Null0
SUPPL43Null0
SUPPL44Null0
SUPPL45Null0
SUPPL49Null0
SUPPL51Null0
SUPPL52Null6
SUPPL61Null7
SUPPL62Null15
SUPPL63Null6
SUPPL64Null6
SUPPL65Null0
SUPPL66Null15
SUPPL69Null7
SUPPL70Null15

TE Codes

003PrescriptionAB
004PrescriptionAB
008PrescriptionAB

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19898
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAVACHOL","activeIngredients":"PRAVASTATIN SODIUM","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PRAVACHOL","activeIngredients":"PRAVASTATIN SODIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PRAVACHOL","activeIngredients":"PRAVASTATIN SODIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PRAVACHOL","activeIngredients":"PRAVASTATIN SODIUM","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/05\/2016","submission":"SUPPL-66","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019898s066lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2012","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019898s063s064lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2012","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019898s063s064lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2012","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019898s062lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2011","submission":"SUPPL-61","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019898s061lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2007","submission":"SUPPL-60","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019898s060lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2005","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/019898s058lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2003","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19898slr054_pravachol_lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2002","submission":"SUPPL-52","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19898s052lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2002","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19898s50lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2001","submission":"SUPPL-46","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19898s46lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2001","submission":"SUPPL-42","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19898s42lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PRAVACHOL","submission":"PRAVASTATIN SODIUM","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PRAVACHOL","submission":"PRAVASTATIN SODIUM","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRAVACHOL","submission":"PRAVASTATIN SODIUM","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PRAVACHOL","submission":"PRAVASTATIN SODIUM","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-07-05
        )

)
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