Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063023
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHALEXIN CEPHALEXIN EQ 250MG BASE TABLET;ORAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/12/1989 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
08/21/2012 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

02/22/2011 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

11/16/2009 SUPPL-23 Labeling

Label is not available on this site.

09/27/2007 SUPPL-21 Labeling

Label is not available on this site.

02/08/2007 SUPPL-20 Labeling

Label is not available on this site.

12/19/2003 SUPPL-17 Labeling

Label is not available on this site.

07/22/2003 SUPPL-16 Labeling

Label is not available on this site.

10/24/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

01/18/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/28/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/13/1993 SUPPL-2 Labeling

Label is not available on this site.

11/12/1992 SUPPL-1 Labeling

Label is not available on this site.

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