Amoxicillin

ANDA 65344, held by Chartwell Rx. Amoxicillin.

As of Nov 14, 2026, ANDA 65344 (Amoxicillin), held by Chartwell Rx, was first approved by FDA on Jan 15, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 15, 2009
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 15, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amoxicillin875MG · tablet;oral	Amoxicillin	Discontinued

All 5 submissions, including labeling and manufacturing supplements


May 1, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Apr 25, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Apr 25, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Apr 25, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Jan 15, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 65344
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