Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 1MG | 1 | BUMEX | BUMETANIDE |
| 002 | TABLET;ORAL | 0.5MG | 1 | BUMEX | BUMETANIDE |
| 003 | TABLET;ORAL | 2MG | 1 | BUMEX | BUMETANIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1983-02-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1985-06-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1984-02-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1985-09-06 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1989-01-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1987-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-08-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1991-03-01 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1993-10-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1998-02-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-08-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-11-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-01-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2002-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2002-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2003-05-13 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2010-01-21 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2015-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2017-05-04 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2018-08-08 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 28 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 18225
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)