Documents
Application Sponsors
NDA 020412 | BRISTOL MYERS SQUIBB | |
Marketing Status
Discontinued | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Application Products
001 | CAPSULE;ORAL | 5MG | 0 | ZERIT | STAVUDINE |
002 | CAPSULE;ORAL | 15MG | 1 | ZERIT | STAVUDINE |
003 | CAPSULE;ORAL | 20MG | 1 | ZERIT | STAVUDINE |
004 | CAPSULE;ORAL | 30MG | 1 | ZERIT | STAVUDINE |
005 | CAPSULE;ORAL | 40MG | 1 | ZERIT | STAVUDINE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1994-06-24 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 2 | AP | 1995-12-21 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-02-09 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 4 | AP | 1996-09-06 | PRIORITY |
LABELING; Labeling | SUPPL | 5 | AP | 1998-02-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-09-26 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-02-03 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-01-16 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-08-19 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 10 | AP | 1999-07-01 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 1998-09-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1999-06-10 | PRIORITY |
LABELING; Labeling | SUPPL | 13 | AP | 2000-09-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-04-17 | PRIORITY |
LABELING; Labeling | SUPPL | 15 | AP | 2001-10-16 | STANDARD |
EFFICACY; Efficacy | SUPPL | 16 | AP | 2002-03-29 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2002-02-20 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2002-02-20 | STANDARD |
LABELING; Labeling | SUPPL | 23 | AP | 2004-06-04 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2005-12-20 | PRIORITY |
LABELING; Labeling | SUPPL | 27 | AP | 2007-06-20 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2008-04-14 | STANDARD |
LABELING; Labeling | SUPPL | 30 | AP | 2008-04-14 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2008-12-11 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2009-02-13 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2009-07-08 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2010-12-10 | STANDARD |
REMS; REMS | SUPPL | 37 | AP | 2011-05-11 | N/A |
LABELING; Labeling | SUPPL | 38 | AP | 2011-11-18 | 901 REQUIRED |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2015-07-14 | PRIORITY |
LABELING; Labeling | SUPPL | 40 | AP | 2017-12-19 | STANDARD |
LABELING; Labeling | SUPPL | 41 | AP | 2018-12-17 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 41 |
SUPPL | 3 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 26 |
SUPPL | 24 | Null | 0 |
SUPPL | 32 | Null | 4 |
SUPPL | 36 | Null | 7 |
SUPPL | 37 | Null | 6 |
SUPPL | 38 | Null | 6 |
SUPPL | 39 | Null | 0 |
SUPPL | 40 | Null | 15 |
SUPPL | 41 | Null | 6 |
TE Codes
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
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"]
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[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
)
)