Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018538
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LOZOL INDAPAMIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
LOZOL INDAPAMIDE 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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
09/03/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018538s028lbl.pdf

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