Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062591
Company: ACS DOBFAR

Products on ANDA 062591

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KEFUROX	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Discontinued	None	No	No
KEFUROX	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
KEFUROX	CEFUROXIME SODIUM	EQ 7.5GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062591

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/1986	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
11/12/2002	SUPPL-38	Labeling		Label is not available on this site.
11/12/2002	SUPPL-37	Labeling		Label is not available on this site.
11/12/2002	SUPPL-36	Labeling		Label is not available on this site.
11/12/2002	SUPPL-35	Labeling		Label is not available on this site.
09/04/2002	SUPPL-34	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/05/2001	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
01/22/2001	SUPPL-32	Labeling		Label is not available on this site.
01/22/2001	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
01/22/2001	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
01/22/2001	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
01/20/1999	SUPPL-26	Labeling		Label is not available on this site.
01/20/1999	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
08/15/1996	SUPPL-23	Labeling		Label is not available on this site.
08/15/1996	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
01/23/1997	SUPPL-20	Labeling		Label is not available on this site.
01/13/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
01/23/1997	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/12/1992	SUPPL-16	Labeling		Label is not available on this site.
12/10/1991	SUPPL-15	Labeling		Label is not available on this site.
02/03/1994	SUPPL-11	Labeling		Label is not available on this site.
06/12/1992	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.