Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017688
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LASIX FUROSEMIDE 10MG/ML SOLUTION;ORAL Discontinued None No 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
03/08/1977 ORIG-1 Approval Type 3 - New Dosage Form 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
06/24/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/01/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/07/1994 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1993 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/26/1995 SUPPL-18 Labeling

Label is not available on this site.

11/13/1992 SUPPL-17 Labeling

Label is not available on this site.

06/09/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1991 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/23/1991 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1991 SUPPL-13 Labeling

Label is not available on this site.

11/09/1990 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/19/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1990 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/15/1990 SUPPL-9 Labeling

Label is not available on this site.

05/29/1984 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/23/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1990 SUPPL-6 Labeling

Label is not available on this site.

01/09/1981 SUPPL-5 Labeling

Label is not available on this site.

07/10/1979 SUPPL-4 Labeling

Label is not available on this site.

04/14/1978 SUPPL-3 Labeling

Label is not available on this site.

04/14/1978 SUPPL-2 Labeling

Label is not available on this site.

04/14/1978 SUPPL-1 Labeling

Label is not available on this site.

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