Cephalexin

ANDA 62117, held by Facta Farma. Cephalexin.

As of Nov 14, 2026, ANDA 62117 (Cephalexin), held by Facta Farma, was first approved by FDA on Mar 27, 1978, with 14 approved supplements and 0 published complete response letters.

First approved: Mar 27, 1978
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Mar 27, 1978	Original application	Approved	None posted

Products

3 strengths and forms


CephalexinEQ 100MG BASE/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for suspension;oral	Cephalexin	Discontinued
CephalexinEQ 125MG BASE/5ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for suspension;oral	Cephalexin	Discontinued
CephalexinEQ 250MG BASE/5ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for suspension;oral	Cephalexin	Discontinued

All 15 submissions, including labeling and manufacturing supplements


May 1, 2000	Supplement 34Manufacturing	Approved	None posted
Jun 1, 1999	Supplement 33Manufacturing	Approved	None posted
Sep 19, 1996	Supplement 32Manufacturing	Approved	None posted
Aug 6, 1996	Supplement 31Labeling	Approved	None posted
Jul 12, 1996	Supplement 28Labeling	Approved	None posted
Mar 1, 1995	Supplement 30Labeling	Approved	None posted
Jun 23, 1994	Supplement 29Manufacturing	Approved	None posted
Oct 25, 1993	Supplement 26Manufacturing	Approved	None posted
Oct 1, 1993	Supplement 27Labeling	Approved	None posted
Jun 30, 1993	Supplement 25Manufacturing	Approved	None posted
Jan 21, 1993	Supplement 24Manufacturing	Approved	None posted
Nov 24, 1992	Supplement 21Labeling	Approved	None posted
Feb 7, 1992	Supplement 20Labeling	Approved	None posted
Feb 28, 1989	Supplement 19Manufacturing	Approved	None posted
Mar 27, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 62117
Drugs@FDA: Overview at FDA
Company: Facta Farma

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