Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050614
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFTAB CEPHALEXIN HYDROCHLORIDE EQ 250MG BASE TABLET;ORAL Discontinued None No No
KEFTAB CEPHALEXIN HYDROCHLORIDE EQ 500MG BASE TABLET;ORAL Discontinued None No No
KEFTAB CEPHALEXIN HYDROCHLORIDE EQ 333MG BASE TABLET;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
10/29/1987 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/18/2001 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/15/2000 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/29/1999 SUPPL-19 Labeling

Label is not available on this site.

07/29/1999 SUPPL-18 Labeling

Label is not available on this site.

02/19/1998 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/29/1999 SUPPL-16 Labeling

Label is not available on this site.

09/02/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/16/1988 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1993 SUPPL-13 Labeling

Label is not available on this site.

10/25/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1991 SUPPL-10 Labeling

Label is not available on this site.

11/28/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/08/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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