Glyburide (Micronized)

ANDA 74591, held by Strides Pharma Intl. Glyburide.

As of Nov 14, 2026, ANDA 74591 (Glyburide (Micronized)), held by Strides Pharma Intl, was first approved by FDA on Dec 22, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1997
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 22, 1997	Original application	Approved	None posted

Products

4 strengths and forms


Glyburide (Micronized)1.5MG · tablet;oral	Glyburide	Discontinued
Glyburide (Micronized)3MG · tablet;oral	Glyburide	Discontinued
Glyburide (Micronized)4.5MG · tablet;oral	Glyburide	Discontinued
Glyburide (Micronized)6MG · tablet;oral	Glyburide	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Mar 23, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Mar 23, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Aug 27, 2001	Supplement 1Manufacturing	Approved	None posted
Dec 22, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74591
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

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