BRISTOL MYERS SQUIBB FDA Approval NDA 020412

NDA 020412

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #020412

Documents

Letter2002-03-29
Letter2004-06-07
Letter2007-04-25
Letter2007-06-14
Letter2008-04-16
Letter2008-04-16
Letter2008-12-18
Letter2009-07-15
Letter2010-12-28
Letter2011-05-16
Label2002-03-29
Label2008-04-23
Label2010-12-23
Letter2002-02-20
Letter2002-02-20
Letter2009-02-18
Letter2011-11-22
Label2003-04-22
Label2004-06-07
Label2007-02-05
Label2008-04-23
Label2009-01-02
Label2009-02-20
Label2009-07-09
Label2011-11-22
Label2017-12-21
Letter2017-12-27
Label2018-12-18
Medication Guide2018-12-18
Letter2018-12-21

Application Sponsors

NDA 020412BRISTOL MYERS SQUIBB

Marketing Status

Discontinued001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001CAPSULE;ORAL5MG0ZERITSTAVUDINE
002CAPSULE;ORAL15MG1ZERITSTAVUDINE
003CAPSULE;ORAL20MG1ZERITSTAVUDINE
004CAPSULE;ORAL30MG1ZERITSTAVUDINE
005CAPSULE;ORAL40MG1ZERITSTAVUDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1994-06-24PRIORITY
EFFICACY; EfficacySUPPL2AP1995-12-21UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-02-09PRIORITY
EFFICACY; EfficacySUPPL4AP1996-09-06PRIORITY
LABELING; LabelingSUPPL5AP1998-02-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1997-09-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1998-02-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1998-01-16PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-08-19PRIORITY
EFFICACY; EfficacySUPPL10AP1999-07-01STANDARD
LABELING; LabelingSUPPL11AP1998-09-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1999-06-10PRIORITY
LABELING; LabelingSUPPL13AP2000-09-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-04-17PRIORITY
LABELING; LabelingSUPPL15AP2001-10-16STANDARD
EFFICACY; EfficacySUPPL16AP2002-03-29STANDARD
LABELING; LabelingSUPPL17AP2002-02-20STANDARD
LABELING; LabelingSUPPL18AP2002-02-20STANDARD
LABELING; LabelingSUPPL23AP2004-06-04STANDARD
LABELING; LabelingSUPPL24AP2005-12-20PRIORITY
LABELING; LabelingSUPPL27AP2007-06-20STANDARD
LABELING; LabelingSUPPL29AP2008-04-14STANDARD
LABELING; LabelingSUPPL30AP2008-04-14STANDARD
LABELING; LabelingSUPPL32AP2008-12-11STANDARD
LABELING; LabelingSUPPL33AP2009-02-13STANDARD
LABELING; LabelingSUPPL34AP2009-07-08STANDARD
LABELING; LabelingSUPPL36AP2010-12-10STANDARD
REMS; REMSSUPPL37AP2011-05-11N/A
LABELING; LabelingSUPPL38AP2011-11-18901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2015-07-14PRIORITY
LABELING; LabelingSUPPL40AP2017-12-19STANDARD
LABELING; LabelingSUPPL41AP2018-12-17STANDARD

Submissions Property Types

ORIG1Null41
SUPPL3Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL12Null0
SUPPL14Null0
SUPPL16Null26
SUPPL24Null0
SUPPL32Null4
SUPPL36Null7
SUPPL37Null6
SUPPL38Null6
SUPPL39Null0
SUPPL40Null15
SUPPL41Null6

TE Codes

002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20412
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020412s041,020413s033lbl.pdf#page=29"]
            [products] => [{"drugName":"ZERIT","activeIngredients":"STAVUDINE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZERIT","activeIngredients":"STAVUDINE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZERIT","activeIngredients":"STAVUDINE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZERIT","activeIngredients":"STAVUDINE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZERIT","activeIngredients":"STAVUDINE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2018","submission":"SUPPL-41","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020412s041,020413s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2018","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020412s041,020413s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020412s040,020413s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020412s040,020413s032lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-38","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020412s038,020413s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2010","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020412s036,020413s028lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2010","submission":"SUPPL-36","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020412s036,020413s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2009","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020412s034,020413s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2009","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020413s025,020412s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2008","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020412s032,020413s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2008","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020412s030,020413s021lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2008","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020412s029,020413s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2005","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020412s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2004","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20412slr023,20413slr014_zerit_lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2002","submission":"SUPPL-16","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20412s16lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2001","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20412s15lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZERIT","submission":"STAVUDINE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZERIT","submission":"STAVUDINE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZERIT","submission":"STAVUDINE","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZERIT","submission":"STAVUDINE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZERIT","submission":"STAVUDINE","actionType":"40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-17
        )

)
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