Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018413
Company: CHARTWELL RX

Products on NDA 018413

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Discontinued	None	No	No
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018413

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/1983	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/07/2015	SUPPL-62	Manufacturing (CMC)		Label is not available on this site.
07/11/2012	SUPPL-60	Labeling-Package Insert		Label is not available on this site.
12/27/2010	SUPPL-58	Labeling-Package Insert		Label is not available on this site.
03/12/2009	SUPPL-54	Labeling		Label is not available on this site.
02/06/2009	SUPPL-51	Labeling		Label is not available on this site.
02/06/2009	SUPPL-49	Labeling		Label is not available on this site.
07/29/2002	SUPPL-39	Manufacturing (CMC)-Facility		Label is not available on this site.
10/24/2002	SUPPL-38	Manufacturing (CMC)-Facility		Label is not available on this site.
09/12/2001	SUPPL-36	Manufacturing (CMC)-Facility		Label is not available on this site.
04/14/2001	SUPPL-35	Manufacturing (CMC)-Facility		Label is not available on this site.
02/09/2000	SUPPL-34	Labeling		Label is not available on this site.
01/28/2000	SUPPL-33	Manufacturing (CMC)-Facility		Label is not available on this site.
02/09/2000	SUPPL-32	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/20/1999	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
06/08/1999	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
06/08/1999	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
06/08/1999	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
06/08/1999	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
02/01/1999	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
04/30/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
05/30/1997	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
02/03/1993	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/11/1992	SUPPL-20	Labeling		Label is not available on this site.
10/27/1995	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/20/1992	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/20/1992	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/07/1992	SUPPL-16	Labeling		Label is not available on this site.
06/25/1991	SUPPL-15	Labeling		Label is not available on this site.
08/05/1988	SUPPL-13	Labeling		Label is not available on this site.
04/25/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/25/1988	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/25/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/15/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/15/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/15/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/15/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.