Amoxil

NDA 50760, held by US Antibiotics. Amoxicillin.

As of Nov 13, 2026, NDA 50760 (Amoxil), held by US Antibiotics, was first approved by FDA on Apr 15, 1999, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 15, 1999
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. 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 21 submissions below

Date	Submission	Status	Documents
Apr 15, 1999	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
Amoxil200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for suspension;oral	Amoxicillin	DiscontinuedReference drug
Amoxil400MG/5ML · for suspension;oral	Amoxicillin	RxReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 1, 2024	Supplement 23Labeling · Standard review	Approved	Label Letter
Nov 2, 2022	Supplement 21Labeling · Standard review	Approved	Label Letter
Dec 3, 2015	Supplement 20Labeling · Standard review	Approved	Letter Label
Sep 24, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Jul 30, 2014	Supplement 16Manufacturing · Standard review	Approved	None posted
May 29, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 16, 2011	Supplement 15Labeling	Approved	Letter Label
Nov 16, 2011	Supplement 13Labeling · Standard review	Approved	Letter Label
Nov 16, 2011	Supplement 12Labeling · Standard review	Approved	Letter Label
Jun 9, 2008	Supplement 10Labeling · Standard review	Approved	Letter Label
Mar 28, 2008	Supplement 11Labeling · Standard review	Approved	Letter Label
Jan 26, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 13, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Dec 18, 2003	Supplement 7Labeling · Standard review	Approved	Letter
May 12, 2003	Supplement 3Labeling · Standard review	Approved	Letter
Dec 4, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
May 1, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 25, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 17, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
May 16, 2000	Supplement 1Labeling · Standard review	Approved	Review
Apr 15, 1999	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 50760
Drugs@FDA: Overview at FDA
Company: US Antibiotics

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