Gemfibrozil

As of Nov 13, 2026, ANDA 73466 (Gemfibrozil), held by Natco, was first approved by FDA on Jan 25, 1993, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 25, 1993
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 25, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemfibrozil300MG · capsule;oral	Gemfibrozil	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 5, 1998	Supplement 2Manufacturing	Approved	None posted
Jan 25, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 73466
Drugs@FDA: Overview at FDA
Company: Natco Corp.

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