Documents
Application Sponsors
Marketing Status
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 002 | TABLET;ORAL | EQ 2.5MG BASE | 1 | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE |
| 003 | TABLET;ORAL | EQ 5MG BASE | 1 | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE |
| 004 | TABLET;ORAL | EQ 10MG BASE | 1 | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE |
| 005 | TABLET;ORAL | EQ 20MG BASE | 1 | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2007-12-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2008-10-08 | N/A |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2010-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2011-12-14 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2012-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2013-09-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2014-10-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2014-10-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2015-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2017-11-30 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 7 |
TE Codes
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 21742
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"BYSTOLIC","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BYSTOLIC","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BYSTOLIC","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BYSTOLIC","activeIngredients":"NEBIVOLOL HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/30\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021742s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2011","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021742s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2010","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021742s007lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BYSTOLIC","submission":"NEBIVOLOL HYDROCHLORIDE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BYSTOLIC","submission":"NEBIVOLOL HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BYSTOLIC","submission":"NEBIVOLOL HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BYSTOLIC","submission":"NEBIVOLOL HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-11-30
)
)