Augmentin '200', Augmentin '400'

Treats infections due to susceptible isolates of the designated bacteria in the…. NDA 50725, held by US Antibiotics. Amoxicillin; Clavulanate Potassium.

As of Nov 13, 2026, NDA 50725 (Augmentin '200', Augmentin '400'), held by US Antibiotics, was first approved by FDA on May 31, 1996, with 32 approved supplements and 0 published complete response letters.

First approved: May 31, 1996
Review: Standard
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
May 31, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Augmentin '200'200MG/5ML;EQ 28.5MG BASE/5ML · for suspension;oral	Amoxicillin; Clavulanate Potassium	DiscontinuedReference drug
Augmentin '400'400MG/5ML;EQ 57MG BASE/5ML · for suspension;oral	Amoxicillin; Clavulanate Potassium	DiscontinuedReference drug

All 33 submissions, including labeling and manufacturing supplements


Jul 17, 2026	Supplement 37Labeling · Standard review	Approved	Label Letter
May 1, 2024	Supplement 36Labeling · Standard review	Approved	Letter Label
Aug 25, 2022	Supplement 35Labeling · Standard review	Approved	Label Letter
Apr 17, 2015	Supplement 34Manufacturing · Standard review	Approved	None posted
Sep 30, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 22, 2013	Supplement 30Labeling	Approved	Letter Label
Jan 22, 2013	Supplement 28Labeling · Standard review	Approved	Letter Label
Sep 29, 2011	Supplement 27Labeling · Standard review	Approved	Letter Label
Dec 4, 2008	Supplement 25Labeling · Standard review	Approved	Letter Label
Mar 27, 2008	Supplement 26Labeling · Standard review	Approved	Letter Label
Aug 11, 2004	Supplement 24Labeling · Standard review	Approved	Letter
Jun 3, 2004	Supplement 23Labeling · Standard review	Approved	Letter
Dec 23, 2003	Supplement 22	Approved	Review
Jun 13, 2003	Supplement 21	Approved	Review
May 12, 2003	Supplement 17Labeling · Standard review	Approved	Review Letter
Dec 4, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 27, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 17, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 7, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 4Labeling · Standard review	Approved	Review Letter
Dec 7, 2001	Supplement 14Manufacturing · Standard review	Approved	Review
May 3, 2001	Supplement 10Manufacturing · Standard review	Approved	Review
Apr 17, 2001	Supplement 13Manufacturing · Standard review	Approved	Review
Mar 7, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 27, 2000	Supplement 11Manufacturing · Standard review	Approved	Review
Jun 8, 2000	Supplement 8Manufacturing · Standard review	Approved	Review
Nov 19, 1999	Supplement 7Manufacturing · Standard review	Approved	Review
Sep 23, 1999	Supplement 6Manufacturing · Standard review	Approved	Review
Feb 1, 1999	Supplement 5Manufacturing · Standard review	Approved	Review
Feb 19, 1998	Supplement 3Manufacturing · Standard review	Approved	Review
Feb 11, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Mar 19, 1997	Supplement 1Labeling · Standard review	Approved	None posted
May 31, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50725
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