Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOZOL | INDAPAMIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LOZOL | INDAPAMIDE | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/06/1983 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/02/2021 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018538s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018538Orig1s030ltr.pdf | |
| 09/03/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018538s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018538s028ltr.pdf | |
| 03/07/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/2000 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/11/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1996 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/29/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/31/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/19/1993 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-17 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 06/24/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/01/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1990 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/13/1989 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/10/1989 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/03/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1989 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/30/1987 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1983 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/29/1983 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/02/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018538s030lbl.pdf | |
| 09/03/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018538s028lbl.pdf |