Application Sponsors
| NDA 017688 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 10MG/ML | 0 | LASIX | FUROSEMIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1977-03-08 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1978-04-14 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1978-04-14 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1979-07-10 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1981-01-09 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1990-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1982-08-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1984-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1990-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1990-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1991-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1990-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1991-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1991-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1991-11-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1992-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1992-11-13 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1995-01-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1993-08-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1994-12-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1995-05-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1996-06-24 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 17688
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"LASIX","activeIngredients":"FUROSEMIDE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LASIX","submission":"FUROSEMIDE","actionType":"10MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)