Amoxicillin

As of Nov 14, 2026, ANDA 65255 (Amoxicillin), held by Hikma, was first approved by FDA on Mar 29, 2006, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 29, 2006
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. Infections of the Genitourinary Tract: Amoxicillin tablets are

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 29, 2006	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amoxicillin875MG · tablet;oral	Amoxicillin	Rx

All 6 submissions, including labeling and manufacturing supplements


May 1, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Apr 25, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Dec 2, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Mar 7, 2013	Supplement 8Labeling	Approved	None posted
Mar 31, 2009	Supplement 3Labeling	Approved	None posted
Mar 29, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 65255
Drugs@FDA: Overview at FDA
Company: Hikma

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