Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061969
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Discontinued 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
04/26/1976 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
02/01/2006 SUPPL-28 Labeling

Label is not available on this site.

12/20/2001 SUPPL-25 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/31/2001 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/20/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/28/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/28/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/02/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/10/1998 SUPPL-18 Labeling

Label is not available on this site.

05/30/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/14/1993 SUPPL-16 Labeling

Label is not available on this site.

03/23/1993 SUPPL-15 Labeling

Label is not available on this site.

12/04/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/12/1992 SUPPL-13 Labeling

Label is not available on this site.

11/10/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/09/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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