Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016363
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LASIX FUROSEMIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
03/20/1968 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/1996 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

08/04/1995 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1996 SUPPL-56 Labeling

Label is not available on this site.

04/03/1995 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1995 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

01/26/1995 SUPPL-53 Labeling

Label is not available on this site.

07/09/1993 SUPPL-52 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/02/1993 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1993 SUPPL-50 Labeling

Label is not available on this site.

07/07/1993 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

01/26/1995 SUPPL-48 Labeling

Label is not available on this site.

11/13/1992 SUPPL-47 Labeling

Label is not available on this site.

01/15/1992 SUPPL-46 Labeling

Label is not available on this site.

09/14/1990 SUPPL-45 Labeling

Label is not available on this site.

01/05/1990 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1990 SUPPL-43 Labeling

Label is not available on this site.

08/10/1990 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1988 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/1987 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/22/1986 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/01/1984 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1984 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/22/1982 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/1983 SUPPL-35 Labeling

Label is not available on this site.

06/04/1982 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1986 SUPPL-33 Labeling

Label is not available on this site.

08/28/1981 SUPPL-32 Labeling

Label is not available on this site.

12/07/2007 SUPPL-31 Efficacy-New Dosing Regimen

Label is not available on this site.

02/05/1981 SUPPL-30 Efficacy

Label is not available on this site.

03/05/1981 SUPPL-29 Labeling

Label is not available on this site.

06/25/1979 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1979 SUPPL-27 Labeling

Label is not available on this site.

11/12/1979 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1979 SUPPL-25 Labeling

Label is not available on this site.

02/22/1979 SUPPL-24 Labeling

Label is not available on this site.

04/14/1978 SUPPL-23 Labeling

Label is not available on this site.

04/14/1978 SUPPL-22 Labeling

Label is not available on this site.

12/07/2007 SUPPL-21 Labeling

Label is not available on this site.

08/21/1979 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1976 SUPPL-18 Labeling

Label is not available on this site.

09/29/1975 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-16 Labeling

Label is not available on this site.

03/20/1975 SUPPL-2 Unspecified

Label is not available on this site.

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