Application Sponsors
NDA 018025 | INTL MEDICATION | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 10MG/ML | 0 | FUROSEMIDE | FUROSEMIDE |
FDA Submissions
| ORIG | 1 | AP | 1979-01-10 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1985-05-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1985-06-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1987-05-01 | |
LABELING; Labeling | SUPPL | 22 | AP | 1991-03-15 | |
LABELING; Labeling | SUPPL | 23 | AP | 1992-04-29 | |
LABELING; Labeling | SUPPL | 24 | AP | 1992-03-17 | |
LABELING; Labeling | SUPPL | 25 | AP | 1992-03-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1992-12-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1993-10-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1998-01-14 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1994-06-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1994-06-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1995-09-19 | |
LABELING; Labeling | SUPPL | 32 | AP | 1998-03-05 | |
LABELING; Labeling | SUPPL | 33 | AP | 1999-09-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2002-10-21 | |
Submissions Property Types
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 27 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 30 | Null | 0 |
SUPPL | 31 | Null | 0 |
SUPPL | 34 | Null | 0 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 18025
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)