Amoxicillin

ANDA 65387, held by Sandoz. Amoxicillin.

As of Nov 14, 2026, ANDA 65387 (Amoxicillin), held by Sandoz, was first approved by FDA on Mar 26, 2007, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 26, 2007
Supplements approved: 6
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 is 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 is

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 26, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Amoxicillin125MG/5ML · for suspension;oral	Amoxicillin	Rx
Amoxicillin250MG/5ML · for suspension;oral	Amoxicillin	Rx

All 7 submissions, including labeling and manufacturing supplements


May 1, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Apr 25, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Nov 25, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Feb 22, 2013	Supplement 8Labeling · Standard review	Approved	None posted
Mar 26, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 65387
Drugs@FDA: Overview at FDA
Company: Sandoz

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