Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062659
Company: SANOFI AVENTIS US

Products on ANDA 062659

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLAFORAN	CEFOTAXIME SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
CLAFORAN	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062659

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/13/1987	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
04/28/2010	SUPPL-42	Labeling		Label is not available on this site.
11/02/2015	SUPPL-41	Labeling		Label is not available on this site.
10/31/2008	SUPPL-40	Labeling		Label is not available on this site.
11/01/2005	SUPPL-35	Labeling		Label is not available on this site.
11/01/2005	SUPPL-34	Labeling		Label is not available on this site.
06/18/2002	SUPPL-31	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/01/2001	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
08/13/2001	SUPPL-29	Manufacturing (CMC)-Facility		Label is not available on this site.
03/19/2001	SUPPL-28	Manufacturing (CMC)-Facility		Label is not available on this site.
02/07/2001	SUPPL-27	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/08/2000	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
07/09/1998	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
03/17/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
03/17/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
08/10/1998	SUPPL-20	Labeling		Label is not available on this site.
12/20/1995	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/20/1995	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/31/1996	SUPPL-15	Labeling		Label is not available on this site.
07/14/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/14/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/31/1996	SUPPL-12	Labeling		Label is not available on this site.
07/31/1996	SUPPL-11	Labeling		Label is not available on this site.
07/31/1996	SUPPL-9	Labeling		Label is not available on this site.
11/09/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/09/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/17/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/17/1992	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/30/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/07/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.