Amoxil

NDA 50542, held by US Antibiotics. Amoxicillin.

As of Nov 13, 2026, NDA 50542 (Amoxil), held by US Antibiotics, was first approved by FDA on Oct 21, 1980, with 28 approved supplements and 0 published complete response letters.

First approved: Oct 21, 1980
Review: Standard
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below


Feb 27, 1998	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review
Oct 21, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Amoxil250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Amoxicillin	DiscontinuedReference drug
Amoxil125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Amoxicillin	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements


May 1, 2024	Supplement 32Labeling · Standard review	Approved	Label Letter
Nov 2, 2022	Supplement 31Labeling · Standard review	Approved	Label Letter
Dec 3, 2015	Supplement 30Labeling · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 29Labeling · Standard review	Approved	Label Letter
Nov 16, 2011	Supplement 28Labeling	Approved	Label Letter
Nov 16, 2011	Supplement 27Labeling · Standard review	Approved	Letter Label
Nov 16, 2011	Supplement 26Labeling · Standard review	Approved	Letter Label
Jun 9, 2008	Supplement 24Labeling · Standard review	Approved	Letter Label
Mar 28, 2008	Supplement 25Labeling · Standard review	Approved	Letter Label
Jan 26, 2006	Supplement 23Labeling · Standard review	Approved	None posted
Jul 13, 2004	Supplement 22Labeling · Standard review	Approved	Letter
Dec 18, 2003	Supplement 21Labeling · Standard review	Approved	Letter
May 12, 2003	Supplement 19Labeling · Standard review	Approved	Letter
Dec 4, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 16Labeling · Standard review	Approved	Review Letter
Apr 17, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
May 16, 2000	Supplement 17Labeling · Standard review	Approved	Review
Feb 27, 1998	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review
Feb 27, 1998	Supplement 10Labeling · Standard review	Approved	Review
Feb 27, 1998	Supplement 5Labeling	Approved	Review
Feb 12, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 10, 1995	Supplement 8Labeling · Standard review	Approved	None posted
Sep 13, 1993	Supplement 7Labeling · Standard review	Approved	None posted
Apr 23, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 10, 1991	Supplement 6Labeling	Approved	None posted
Feb 8, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 12, 1988	Supplement 2Labeling	Approved	None posted
Dec 17, 1985	Supplement 1Labeling	Approved	None posted
Oct 21, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50542
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