Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZEBETA | BISOPROLOL FUMARATE |
| 002 | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZEBETA | BISOPROLOL FUMARATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1992-07-31 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1995-05-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-01-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2000-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2003-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2007-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2011-02-03 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2013-08-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2014-06-12 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 19982
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)