Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017688
Company: SANOFI AVENTIS US

Products on NDA 017688

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LASIX	FUROSEMIDE	10MG/ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017688

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.