Trimox

ANDA 63099, held by Apothecon. Amoxicillin.

As of Nov 14, 2026, ANDA 63099 (Trimox), held by Apothecon, was first approved by FDA on Mar 20, 1992, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 20, 1992
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 20, 1992	Original application	Approved	None posted

Products

2 strengths and forms


Trimox250MG · capsule;oral	Amoxicillin	Discontinued
Trimox500MG · capsule;oral	Amoxicillin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


May 8, 2002	Supplement 2Manufacturing	Approved	None posted
Feb 18, 1999	Supplement 1Labeling	Approved	None posted
Mar 20, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 63099
Drugs@FDA: Overview at FDA
Company: Apothecon

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