Amoxicillin

ANDA 64076, held by Sandoz. Amoxicillin.

As of Nov 14, 2026, ANDA 64076 (Amoxicillin), held by Sandoz, was first approved by FDA on Sep 30, 1994, with 19 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1994
Supplements approved: 19
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 20 submissions below

Date	Submission	Status	Documents
Sep 30, 1994	Original application	Approved	None posted

Products

2 strengths and forms


Amoxicillin250MG · capsule;oral	Amoxicillin	Rx
Amoxicillin500MG · capsule;oral	Amoxicillin	Rx

All 20 submissions, including labeling and manufacturing supplements


May 1, 2024	Supplement 38Labeling · Standard review	Approved	None posted
Apr 25, 2024	Supplement 37Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 31Labeling · Standard review	Approved	None posted
Jun 3, 2020	Supplement 30Labeling · Standard review	Approved	None posted
Nov 25, 2014	Supplement 27Labeling · Standard review	Approved	None posted
Feb 22, 2013	Supplement 25Labeling · Standard review	Approved	None posted
May 31, 2007	Supplement 18Labeling	Approved	None posted
May 31, 2007	Supplement 17Labeling	Approved	None posted
May 10, 2006	Supplement 16Labeling	Approved	None posted
Sep 9, 2005	Supplement 14Labeling	Approved	None posted
Sep 30, 2004	Supplement 12Labeling	Approved	None posted
Sep 30, 2004	Supplement 11Labeling	Approved	None posted
Apr 6, 2004	Supplement 10Labeling	Approved	None posted
Apr 12, 2001	Supplement 7Manufacturing	Approved	None posted
Dec 21, 2000	Supplement 6Manufacturing	Approved	None posted
Aug 7, 2000	Supplement 5Manufacturing	Approved	None posted
Apr 14, 1997	Supplement 4Manufacturing	Approved	None posted
Nov 8, 1996	Supplement 3Manufacturing	Approved	None posted
Nov 8, 1996	Supplement 1Manufacturing	Approved	None posted
Sep 30, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 64076
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