Documents
Application Sponsors
| NDA 018538 | SANOFI AVENTIS US | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LOZOL | INDAPAMIDE |
| 002 | TABLET;ORAL | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | LOZOL | INDAPAMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1983-07-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1983-10-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1984-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1987-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-07-08 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1988-11-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1988-11-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-02-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1990-01-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1989-07-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1989-10-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1990-03-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1992-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1991-09-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1992-04-01 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1992-06-24 | |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 1993-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1993-08-19 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1993-03-31 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1996-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1996-10-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1996-05-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1996-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1998-01-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1998-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2000-10-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2000-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2009-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2021-03-02 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 30 | Null | 7 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 18538
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"LOZOL","activeIngredients":"INDAPAMIDE","strength":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"LOZOL","activeIngredients":"INDAPAMIDE","strength":"1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/03\/2009","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018538s028lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LOZOL","submission":"INDAPAMIDE","actionType":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"LOZOL","submission":"INDAPAMIDE","actionType":"1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2009-09-03
)
)