Glyburide

ANDA 77537, held by Aurobindo Pharma. Glyburide.

As of Nov 14, 2026, ANDA 77537 (Glyburide), held by Aurobindo Pharma, was first approved by FDA on Oct 18, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 18, 2007
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 18, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Glyburide1.25MG · tablet;oral	Glyburide	Discontinued
Glyburide2.5MG · tablet;oral	Glyburide	Discontinued
Glyburide5MG · tablet;oral	Glyburide	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Oct 6, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Feb 25, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Sep 28, 2012	Supplement 7Labeling	Approved	None posted
Mar 20, 2009	Supplement 4Labeling	Approved	None posted
Dec 31, 2008	Supplement 3Labeling	Approved	None posted
Oct 18, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77537
Drugs@FDA: Overview at FDA
Company: Aurobindo 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