Cephalexin

ANDA 62760, held by Teva. Cephalexin.

As of Nov 13, 2026, ANDA 62760 (Cephalexin), held by Teva, was first approved by FDA on Apr 24, 1987, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 24, 1987
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Apr 24, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CephalexinEQ 250MG BASE · capsule;oral	Cephalexin	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Sep 11, 2000	Supplement 29Manufacturing	Approved	None posted
Feb 23, 2000	Supplement 27Manufacturing	Approved	None posted
Feb 23, 2000	Supplement 26Manufacturing	Approved	None posted
Feb 23, 2000	Supplement 25Manufacturing	Approved	None posted
Mar 17, 1998	Supplement 24Manufacturing	Approved	None posted
Jul 16, 1996	Supplement 23Labeling	Approved	None posted
Jul 18, 1994	Supplement 22Manufacturing	Approved	None posted
Jun 23, 1994	Supplement 21Manufacturing	Approved	None posted
Jun 23, 1994	Supplement 20Manufacturing	Approved	None posted
Jun 23, 1994	Supplement 19Manufacturing	Approved	None posted
Dec 22, 1993	Supplement 17Manufacturing	Approved	None posted
Dec 7, 1993	Supplement 18Labeling	Approved	None posted
Aug 13, 1993	Supplement 16Labeling	Approved	None posted
May 26, 1993	Supplement 14Manufacturing	Approved	None posted
May 26, 1993	Supplement 13Manufacturing	Approved	None posted
Jul 30, 1992	Supplement 12Labeling	Approved	None posted
Mar 24, 1992	Supplement 10Manufacturing	Approved	None posted
Feb 27, 1992	Supplement 11Labeling	Approved	None posted
Mar 10, 1988	Supplement 6Manufacturing	Approved	None posted
Feb 25, 1988	Supplement 8Manufacturing	Approved	None posted
Apr 24, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 62760
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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