Quinidine Gluconate

ANDA 89338, held by Sun Pharm Industries. Quinidine Gluconate.

As of Nov 15, 2026, ANDA 89338 (Quinidine Gluconate), held by Sun Pharm Industries, was first approved by FDA on Feb 11, 1987, with 21 approved supplements and 0 published complete response letters.

First approved: Feb 11, 1987
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION ), then quinidine gluconate should be discontinued.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Feb 11, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Quinidine Gluconate324MG · tablet, extended release;oral	Quinidine Gluconate	Rx

All 22 submissions, including labeling and manufacturing supplements


Feb 2, 2010	Supplement 36Labeling	Approved	Label
Mar 31, 2003	Supplement 24Labeling	Approved	None posted
Jul 10, 2001	Supplement 20Manufacturing	Approved	None posted
Jun 4, 2001	Supplement 16Manufacturing	Approved	None posted
Jul 17, 2000	Supplement 17Labeling	Approved	None posted
May 16, 2000	Supplement 19Manufacturing	Approved	None posted
May 16, 2000	Supplement 18Manufacturing	Approved	None posted
Feb 4, 1999	Supplement 15Labeling	Approved	None posted
Dec 5, 1997	Supplement 14Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 13Manufacturing	Approved	None posted
Dec 6, 1996	Supplement 12Labeling	Approved	None posted
Apr 25, 1996	Supplement 10Manufacturing	Approved	None posted
Jul 31, 1995	Supplement 9Manufacturing	Approved	None posted
Jun 22, 1995	Supplement 11Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 8Manufacturing	Approved	None posted
Jun 15, 1993	Supplement 7Labeling	Approved	None posted
Jul 16, 1991	Supplement 6Manufacturing	Approved	None posted
Mar 8, 1990	Supplement 5Labeling	Approved	None posted
Jan 12, 1990	Supplement 4Labeling	Approved	None posted
Jul 17, 1987	Supplement 3Manufacturing	Approved	None posted
Jul 17, 1987	Supplement 1Manufacturing	Approved	None posted
Feb 11, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89338
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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