BRISTOL MYERS SQUIBB FDA Approval NDA 021183

NDA 021183

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #021183

Documents

Letter2004-06-30
Letter2002-01-28
Letter2002-01-29
Letter2002-08-05
Letter2002-09-26
Letter2004-01-22
Letter2006-12-28
Letter2008-10-02
Letter2010-02-01
Letter2011-05-12
Letter2011-11-22
Label2002-08-05
Label2002-09-26
Label2003-03-07
Label2006-12-04
Label2009-06-22
Label2010-01-29
Label2011-11-22
Review2004-03-11
Review2007-07-09
Letter2002-04-01
Letter2002-09-26
Letter2003-03-10
Letter2006-09-18
Letter2009-06-16
Label2000-10-31
Label2002-04-01
Label2002-09-26
Label2004-01-22
Label2006-08-21
Label2008-10-03
Review2005-04-08
Other Important Information from FDA2010-08-09
Label2018-01-25
Letter2018-01-30
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2018-12-18
Medication Guide2018-12-18
Letter2018-12-21

Application Sponsors

NDA 021183BRISTOL MYERS SQUIBB

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE, DELAYED REL PELLETS;ORAL125MG1VIDEX ECDIDANOSINE
002CAPSULE, DELAYED REL PELLETS;ORAL200MG1VIDEX ECDIDANOSINE
003CAPSULE, DELAYED REL PELLETS;ORAL250MG1VIDEX ECDIDANOSINE
004CAPSULE, DELAYED REL PELLETS;ORAL400MG1VIDEX ECDIDANOSINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2000-10-31PRIORITY
EFFICACY; EfficacySUPPL2AP2002-01-29STANDARD
EFFICACY; EfficacySUPPL3AP2002-04-01UNKNOWN
LABELING; LabelingSUPPL4AP2002-08-05STANDARD
LABELING; LabelingSUPPL5AP2002-10-16STANDARD
LABELING; LabelingSUPPL6AP2002-10-16STANDARD
LABELING; LabelingSUPPL7AP2003-03-04STANDARD
LABELING; LabelingSUPPL10AP2004-01-21STANDARD
LABELING; LabelingSUPPL15AP2006-08-18STANDARD
LABELING; LabelingSUPPL16AP2006-11-29STANDARD
EFFICACY; EfficacySUPPL20AP2008-09-29PRIORITY
LABELING; LabelingSUPPL22AP2009-06-10STANDARD
REMS; REMSSUPPL23AP2010-01-25UNKNOWN
REMS; REMSSUPPL24AP2011-05-10N/A
LABELING; LabelingSUPPL25AP2011-11-18901 REQUIRED
LABELING; LabelingSUPPL28AP2018-01-25STANDARD
LABELING; LabelingSUPPL29AP2018-12-17STANDARD

Submissions Property Types

SUPPL3Null8
SUPPL20Null6
SUPPL23Null6
SUPPL24Null6
SUPPL25Null7
SUPPL28Null15
SUPPL29Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21183
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/021183s029lbl.pdf#page=33"]
            [products] => [{"drugName":"VIDEX EC","activeIngredients":"DIDANOSINE","strength":"125MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIDEX EC","activeIngredients":"DIDANOSINE","strength":"200MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIDEX EC","activeIngredients":"DIDANOSINE","strength":"250MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIDEX EC","activeIngredients":"DIDANOSINE","strength":"400MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021183s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021183s029lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021183s028lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021183s028lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021183s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2010","submission":"SUPPL-23","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021183s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021183s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2008","submission":"SUPPL-20","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021183s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2006","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020154s50,20155s39,20156s40,21183s16lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2006","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020154s49,20155s38,20156s39,21183s15lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2004","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2003","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2002","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21183s5s6lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2002","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21183s5s6lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2002","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21183s4lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2002","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20154s37lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21183lbl1.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIDEX EC","submission":"DIDANOSINE","actionType":"125MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VIDEX EC","submission":"DIDANOSINE","actionType":"200MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VIDEX EC","submission":"DIDANOSINE","actionType":"250MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"VIDEX EC","submission":"DIDANOSINE","actionType":"400MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-17
        )

)
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