Keftab

NDA 50614, held by Lilly. Cephalexin Hydrochloride.

As of Nov 13, 2026, NDA 50614 (Keftab), held by Lilly, was first approved by FDA on Oct 29, 1987, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1987
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 29, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
KeftabEQ 250MG BASE · tablet;oral	Cephalexin Hydrochloride	Discontinued
KeftabEQ 500MG BASE · tablet;oral	Cephalexin Hydrochloride	Discontinued
KeftabEQ 333MG BASE · tablet;oral	Cephalexin Hydrochloride	Discontinued

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 18, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 15, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 29, 1999	Supplement 19Labeling · Standard review	Approved	None posted
Jul 29, 1999	Supplement 18Labeling · Standard review	Approved	None posted
Jul 29, 1999	Supplement 16Labeling · Standard review	Approved	None posted
Feb 19, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 2, 1993	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 28, 1993	Supplement 13Labeling · Standard review	Approved	None posted
Oct 25, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 6, 1991	Supplement 10Labeling · Standard review	Approved	None posted
Mar 8, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 28, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
May 16, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 29, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50614
Drugs@FDA: Overview at FDA
Company: Lilly

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters