Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050614
Company: LILLY

Products on NDA 050614

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050614

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.