Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 016363
Company: SANOFI AVENTIS US

Products on NDA 016363

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LASIX	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016363

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	Note
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.