Documents
Application Sponsors
| NDA 021797 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 0.5MG | 1 | BARACLUDE | ENTECAVIR |
| 002 | TABLET;ORAL | 1MG | 1 | BARACLUDE | ENTECAVIR |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-03-29 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2007-03-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 3 | AP | 2007-07-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2008-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2008-06-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2009-07-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2009-02-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2010-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2010-12-28 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2012-10-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2012-10-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2013-04-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2013-06-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-12-19 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2014-03-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 2018-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2018-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2019-11-06 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 23 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 21797
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
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[labels] => [{"actionDate":"11\/06\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021797s023,021798s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021797s021,021798s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021797s021,021798s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021797s013s014,021798s014s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2012","submission":"SUPPL-13","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021797s013s014,021798s014s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2010","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021797s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2010","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021797s010,021798s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2009","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"02\/25\/2009","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021797s009,021798s010lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2008","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021797s005,021798s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2007","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021797s003,021798s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2007","submission":"SUPPL-2","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021797s002,021798s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2007","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021797s001,021798s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021797,021798lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BARACLUDE","submission":"ENTECAVIR","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BARACLUDE","submission":"ENTECAVIR","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-11-06
)
)