Amoxil

NDA 50754, held by US Antibiotics. Amoxicillin.

As of Nov 13, 2026, NDA 50754 (Amoxil), held by US Antibiotics, was first approved by FDA on Jul 10, 1998, with 20 approved supplements and 0 published complete response letters.

First approved: Jul 10, 1998
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jul 10, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
Amoxil875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amoxicillin	DiscontinuedReference drug
Amoxil500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amoxicillin	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 1, 2024	Supplement 22Labeling · Standard review	Approved	Letter Label
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
Sep 30, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 16, 2011	Supplement 17Labeling	Approved	Letter Label
Nov 16, 2011	Supplement 14Labeling · Standard review	Approved	Letter Label
Nov 16, 2011	Supplement 13Labeling · Standard review	Approved	Letter Label
Jun 9, 2008	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 28, 2008	Supplement 12Labeling · Standard review	Approved	Letter Label
Jan 26, 2006	Supplement 10Labeling · Standard review	Approved	None posted
Jul 13, 2004	Supplement 9Labeling · Standard review	Approved	Letter
Dec 18, 2003	Supplement 8Labeling · Standard review	Approved	Letter
May 12, 2003	Supplement 4Labeling · Standard review	Approved	Letter
Dec 4, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
May 1, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 25, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 1Labeling · Standard review	Approved	Review Letter
Apr 17, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
May 16, 2000	Supplement 2Labeling · Standard review	Approved	Review
Jul 10, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter

Identifiers

Application: NDA 50754
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