BRISTOL-MYERS SQUIBB FDA Approval NDA 020156

Application #020156

Documents

Letter	1999-10-29
Letter	2002-09-25
Letter	2003-03-10
Letter	2004-01-22
Letter	2006-12-28
Letter	2009-06-17
Letter	2010-02-01
Letter	2011-05-12
Letter	2014-08-12
Label	2003-04-21
Label	2002-04-01
Label	2002-09-25
Label	2002-09-25
Label	2004-01-22
Label	2006-08-21
Label	2006-12-04
Label	2009-06-22
Label	2010-01-29
Label	2014-08-12
Review	2007-08-06
Review	2007-08-06
Review	2004-08-09
Review	2005-04-19
Review	2005-04-27
Letter	2002-04-01
Letter	2002-09-25
Letter	2006-09-18
Letter	2011-11-22
Label	1999-10-21
Label	2003-04-21
Label	2003-03-07
Label	2011-11-22
Review	2005-01-06
Review	2005-04-19
Review	2005-04-27
Review	2007-11-19
Other Important Information from FDA	2010-08-09
Label	2018-01-26
Medication Guide	2018-01-26
Letter	2018-01-30
Label	2018-12-18
Medication Guide	2018-12-18
Letter	2018-12-21

Application Sponsors

NDA 020156

BRISTOL-MYERS SQUIBB

Marketing Status

Prescription

001

Application Products

001

FOR SOLUTION;ORAL

10MG/ML

VIDEX

DIDANOSINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-10-09	PRIORITY
EFFICACY; Efficacy	SUPPL	4	AP	1992-09-25
LABELING; Labeling	SUPPL	5	AP	1994-02-10	STANDARD
LABELING; Labeling	SUPPL	6	AP	1995-08-21	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	1994-08-05	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1995-08-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	1994-02-10	STANDARD
LABELING; Labeling	SUPPL	10	AP	1995-08-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	1995-08-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	1996-06-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	1995-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-03-13
EFFICACY; Efficacy	SUPPL	16	AP	1996-07-17	STANDARD
LABELING; Labeling	SUPPL	17	AP	1996-06-26	STANDARD
LABELING; Labeling	SUPPL	18	AP	1998-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-03-05
EFFICACY; Efficacy	SUPPL	21	AP	1999-07-01	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	1999-10-28	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2000-07-03	STANDARD
LABELING; Labeling	SUPPL	24	AP	2000-07-24	STANDARD
EFFICACY; Efficacy	SUPPL	25	AP	2000-07-24	STANDARD
LABELING; Labeling	SUPPL	26	AP	2001-07-27	STANDARD
LABELING; Labeling	SUPPL	27	AP	2001-09-10	STANDARD
LABELING; Labeling	SUPPL	28	AP	2001-11-16	STANDARD
EFFICACY; Efficacy	SUPPL	29	AP	2002-04-01	UNKNOWN
LABELING; Labeling	SUPPL	31	AP	2002-09-25	STANDARD
LABELING; Labeling	SUPPL	32	AP	2002-09-25	STANDARD
LABELING; Labeling	SUPPL	33	AP	2003-03-04	STANDARD
LABELING; Labeling	SUPPL	35	AP	2004-01-21	STANDARD
LABELING; Labeling	SUPPL	39	AP	2006-08-18	STANDARD
LABELING; Labeling	SUPPL	40	AP	2006-11-29	STANDARD
LABELING; Labeling	SUPPL	44	AP	2009-06-11	STANDARD
REMS; REMS	SUPPL	46	AP	2010-01-25	UNKNOWN
REMS; REMS	SUPPL	47	AP	2011-05-10	N/A
LABELING; Labeling	SUPPL	48	AP	2011-11-18	901 REQUIRED
LABELING; Labeling	SUPPL	51	AP	2014-08-08	STANDARD
LABELING; Labeling	SUPPL	53	AP	2018-01-25	STANDARD
LABELING; Labeling	SUPPL	54	AP	2018-12-17	STANDARD

Submissions Property Types

ORIG	1	Null	11
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	29	Null	26
SUPPL	46	Null	7
SUPPL	47	Null	31
SUPPL	48	Null	6
SUPPL	51	Null	7
SUPPL	53	Null	7
SUPPL	54	Null	15

CDER Filings

BRISTOL-MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20156
            [companyName] => BRISTOL-MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020156s054lbl.pdf#page=34"]
            [products] => [{"drugName":"VIDEX","activeIngredients":"DIDANOSINE","strength":"10MG\/ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2018","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020156s054lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2018","submission":"SUPPL-54","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020156s054lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2018","submission":"SUPPL-53","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020156s053lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2018","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020156s053lbl.pdf\"}]","notes":""},{"actionDate":"08\/08\/2014","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020156s051lbl.pdf\"}]","notes":""},{"actionDate":"08\/08\/2014","submission":"SUPPL-51","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020156s051lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020156s048lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2010","submission":"SUPPL-46","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020156s046lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2009","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020156s044lbl.pdf\"}]","notes":""},{"actionDate":"11\/29\/2006","submission":"SUPPL-40","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-39","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-35","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-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2002","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20154s40,s41lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2002","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20154s40,s41lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2002","submission":"SUPPL-29","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":"11\/16\/2001","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20156s28lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2001","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20156s27lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/1999","submission":"SUPPL-22","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20154LBL.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIDEX","submission":"DIDANOSINE","actionType":"10MG\/ML","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-17
        )

)

NDA 020156

BRISTOL-MYERS SQUIBB

FDA Drug Application

Application #020156

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

BRISTOL-MYERS SQUIBB