Cephalexin

ANDA 65152, held by Chartwell Rx. Cephalexin.

As of Nov 14, 2026, ANDA 65152 (Cephalexin), held by Chartwell Rx, was first approved by FDA on Feb 24, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 24, 2005
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Cephalexin capsules, USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:

Respiratory tract infection
Otitis media
Skin and skin structure infections
Bone infections
Genitourinary tract infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules, USP and other antibacterial drugs, Cephalexin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 24, 2005	Original application	Approved	None posted

Products

2 strengths and forms


CephalexinEQ 250MG BASE · capsule;oral	Cephalexin	Rx
CephalexinEQ 500MG BASE · capsule;oral	Cephalexin	Rx

All 2 submissions, including labeling and manufacturing supplements


Sep 20, 2011	Supplement 1Labeling	Approved	None posted
Feb 24, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 65152
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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