Documents
Application Sponsors
| NDA 021567 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | REYATAZ | ATAZANAVIR SULFATE |
| 002 | CAPSULE;ORAL | EQ 150MG BASE | 1 | REYATAZ | ATAZANAVIR SULFATE |
| 003 | CAPSULE;ORAL | EQ 200MG BASE | 1 | REYATAZ | ATAZANAVIR SULFATE |
| 004 | CAPSULE;ORAL | EQ 300MG BASE | 1 | REYATAZ | ATAZANAVIR SULFATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2003-06-20 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2004-07-06 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 2004-10-05 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2005-07-18 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2006-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2006-08-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2006-10-16 | N/A |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2007-03-22 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2007-12-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2008-03-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 2008-08-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2008-09-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2008-02-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2009-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2010-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2010-04-26 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2011-02-04 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2011-10-17 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2012-02-17 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 28 | AP | 2012-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2013-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2013-08-15 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2013-08-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2014-02-26 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2014-06-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 36 | AP | 2015-02-26 | UNKNOWN |
| LABELING; Labeling | SUPPL | 37 | AP | 2015-03-27 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 38 | AP | 2015-09-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 39 | AP | 2016-09-15 | 901 REQUIRED |
| EFFICACY; Efficacy | SUPPL | 40 | AP | 2017-05-23 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2017-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2018-04-18 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2020-09-24 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 9 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 25 | Null | 31 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 31 | Null | 15 |
| SUPPL | 32 | Null | 6 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 15 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 7 |
| SUPPL | 40 | Null | 15 |
| SUPPL | 41 | Null | 6 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 44 | Null | 15 |
TE Codes
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 21567
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"REYATAZ","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"REYATAZ","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REYATAZ","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REYATAZ","activeIngredients":"ATAZANAVIR SULFATE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/18\/2018","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021567s042,206352s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2017","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021567s041,206352s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2017","submission":"SUPPL-40","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021567s040,206352s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2016","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021567s039,206352s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2015","submission":"SUPPL-38","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206352s003,021567s038lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021567s037,206352s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021567s037,206352s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/02\/2014","submission":"SUPPL-35","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206352s000,021567s035lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2013","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021567s032s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021567s032s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2012","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021567s028lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021567s027lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2011","submission":"SUPPL-26","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021567s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2011","submission":"SUPPL-25","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021567s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2010","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021567s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2010","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021567s022lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2009","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021567s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2008","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021567s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021567s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2008","submission":"SUPPL-15","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021567s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2008","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021567s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2007","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021567s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2007","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021567s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2006","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021567s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2006","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021567s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2006","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021567s008s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2006","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021567s008s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2006","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021567s007lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2005","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021567s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2004","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21567s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2004","submission":"SUPPL-2","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21567se2-002_reyataz_lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21567slr001_reyataz_lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21567_reyataz_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"REYATAZ","submission":"ATAZANAVIR SULFATE","actionType":"EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"REYATAZ","submission":"ATAZANAVIR SULFATE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REYATAZ","submission":"ATAZANAVIR SULFATE","actionType":"EQ 200MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REYATAZ","submission":"ATAZANAVIR SULFATE","actionType":"EQ 300MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-04-18
)
)