BRISTOL-MYERS SQUIBB FDA Approval NDA 020413

Application #020413

Documents

Letter	2002-03-29
Letter	2004-06-07
Letter	2007-04-25
Letter	2007-06-14
Letter	2008-04-16
Letter	2008-04-16
Letter	2008-12-18
Letter	2009-02-18
Letter	2011-11-22
Label	2002-03-29
Label	2008-04-23
Label	2008-04-23
Label	2009-01-02
Label	2009-02-20
Label	2010-12-23
Label	2011-11-22
Letter	2002-02-20
Letter	2002-02-20
Letter	2009-07-15
Letter	2010-12-28
Letter	2011-05-16
Label	2003-04-25
Label	2004-06-07
Label	2007-02-05
Label	2009-07-09
Label	2017-12-21
Letter	2017-12-27
Medication Guide	2018-12-18
Label	2018-12-18
Letter	2018-12-21

Application Sponsors

NDA 020413

BRISTOL-MYERS SQUIBB

Marketing Status

Discontinued

001

Application Products

001

FOR SOLUTION;ORAL

1MG/ML

ZERIT

STAVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-09-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-08-19	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	1999-07-01	STANDARD
LABELING; Labeling	SUPPL	4	AP	1998-09-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2000-09-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2001-10-16	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2002-03-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-02-20	STANDARD
LABELING; Labeling	SUPPL	9	AP	2002-02-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2004-06-04	STANDARD
LABELING; Labeling	SUPPL	15	AP	2005-12-20	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2007-06-20	STANDARD
LABELING; Labeling	SUPPL	20	AP	2008-04-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2008-04-14	N/A
LABELING; Labeling	SUPPL	23	AP	2008-12-11	STANDARD
LABELING; Labeling	SUPPL	25	AP	2009-02-13	STANDARD
LABELING; Labeling	SUPPL	26	AP	2009-07-08	STANDARD
LABELING; Labeling	SUPPL	28	AP	2010-12-10	STANDARD
REMS; REMS	SUPPL	29	AP	2011-05-11	N/A
LABELING; Labeling	SUPPL	30	AP	2011-11-18	901 REQUIRED
LABELING; Labeling	SUPPL	32	AP	2017-12-19	STANDARD
LABELING; Labeling	SUPPL	33	AP	2018-12-17	STANDARD

Submissions Property Types

ORIG	1	Null	11
SUPPL	2	Null	0
SUPPL	7	Null	26
SUPPL	15	Null	0
SUPPL	23	Null	4
SUPPL	28	Null	6
SUPPL	29	Null	6
SUPPL	30	Null	6
SUPPL	32	Null	39
SUPPL	33	Null	6

CDER Filings

BRISTOL-MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20413
            [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":"1MG\/ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/17\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020412s041,020413s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020412s041,020413s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2017","submission":"SUPPL-32","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-32","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-30","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-28","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-28","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-26","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-25","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-23","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-21","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020412s030,020413s021lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2008","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020412s030,020413s021lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2008","submission":"SUPPL-20","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-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020413s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2004","submission":"SUPPL-14","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-7","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-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20413s6lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZERIT","submission":"STAVUDINE","actionType":"1MG\/ML","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-17
        )

)

NDA 020413

BRISTOL-MYERS SQUIBB

FDA Drug Application

Application #020413

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

BRISTOL-MYERS SQUIBB