Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050440
Company: LILLY

Products on NDA 050440

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050440

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.