Glyburide (Micronized)

ANDA 74792, held by Natco Pharma. Glyburide.

As of Nov 14, 2026, ANDA 74792 (Glyburide (Micronized)), held by Natco Pharma, was first approved by FDA on Jun 26, 1998, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 26, 1998
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 26, 1998	Original application	Approved	Letter

Products

3 strengths and forms


Glyburide (Micronized)1.5MG · tablet;oral	Glyburide	Discontinued
Glyburide (Micronized)3MG · tablet;oral	Glyburide	Discontinued
Glyburide (Micronized)6MG · tablet;oral	Glyburide	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Oct 30, 2019	Supplement 15Labeling · Standard review	Approved	None posted
Oct 2, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Sep 28, 2012	Supplement 12Labeling	Approved	None posted
May 19, 2009	Supplement 9Labeling	Approved	None posted
Sep 25, 2001	Supplement 5Labeling	Approved	None posted
Mar 24, 2000	Supplement 4Labeling	Approved	None posted
Aug 17, 1999	Supplement 1Manufacturing	Approved	None posted
Aug 17, 1999	Supplement 2Labeling	Approved	None posted
Aug 17, 1999	Supplement 3Manufacturing	Approved	None posted
Jun 26, 1998	Original application	Approved	Letter

Identifiers

Application: ANDA 74792
Drugs@FDA: Overview at FDA
Company: Natco Pharma

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