Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018025
Company: INTL MEDICATION

Products on NDA 018025

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018025

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/1979	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
10/21/2002	SUPPL-34	Manufacturing (CMC)-Facility		Label is not available on this site.
09/17/1999	SUPPL-33	Labeling		Label is not available on this site.
03/05/1998	SUPPL-32	Labeling		Label is not available on this site.
09/19/1995	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
06/07/1994	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
06/17/1994	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
01/14/1998	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
10/29/1993	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
12/17/1992	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
03/17/1992	SUPPL-25	Labeling		Label is not available on this site.
03/17/1992	SUPPL-24	Labeling		Label is not available on this site.
04/29/1992	SUPPL-23	Labeling		Label is not available on this site.
03/15/1991	SUPPL-22	Labeling		Label is not available on this site.
05/01/1987	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/13/1985	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/08/1985	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.