Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050440
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFLET CEPHALEXIN EQ 500MG BASE TABLET;ORAL Discontinued None No No
KEFLET CEPHALEXIN EQ 1GM BASE TABLET;ORAL Discontinued None No No
KEFLET CEPHALEXIN EQ 250MG 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
10/12/1972 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
09/17/1982 SUPPL-45 Labeling

Label is not available on this site.

09/17/1982 SUPPL-44 Labeling

Label is not available on this site.

09/17/1982 SUPPL-43 Efficacy-New Dosing Regimen

Label is not available on this site.

03/09/1982 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1981 SUPPL-41 Labeling

Label is not available on this site.

02/11/1981 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1980 SUPPL-39 Labeling

Label is not available on this site.

05/12/1980 SUPPL-38 Labeling

Label is not available on this site.

03/19/1980 SUPPL-37 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/04/1980 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1979 SUPPL-35 Labeling

Label is not available on this site.

05/21/1979 SUPPL-34 Labeling

Label is not available on this site.

04/20/1979 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1979 SUPPL-31 Labeling

Label is not available on this site.

11/07/1978 SUPPL-30 Efficacy-New Dosing Regimen

Label is not available on this site.

05/18/1978 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1977 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/11/1977 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1977 SUPPL-26 Labeling

Label is not available on this site.

11/02/1976 SUPPL-25 Labeling

Label is not available on this site.

11/08/1976 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/17/1975 SUPPL-23 Labeling

Label is not available on this site.

10/20/1975 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/20/1975 SUPPL-21 Labeling

Label is not available on this site.

12/27/1974 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/30/1991 SUPPL-19 Labeling

Label is not available on this site.

04/10/1990 SUPPL-18 Labeling

Label is not available on this site.

07/16/1986 SUPPL-11 Labeling

Label is not available on this site.

01/27/1987 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1985 SUPPL-8 Labeling

Label is not available on this site.

09/06/1985 SUPPL-7 Labeling

Label is not available on this site.

09/05/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1983 SUPPL-5 Labeling

Label is not available on this site.

09/28/1983 SUPPL-4 Labeling

Label is not available on this site.

08/15/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/15/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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