Disopyramide Phosphate

ANDA 70173, held by Dr Reddys Labs SA. Disopyramide Phosphate.

As of Nov 15, 2026, ANDA 70173 (Disopyramide Phosphate), held by Dr Reddys Labs SA, was first approved by FDA on May 31, 1985, with 22 approved supplements and 0 published complete response letters.

First approved: May 31, 1985
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Disopyramide phosphate capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
May 31, 1985	Original application	Approved	None posted

Products

2 strengths and forms


Disopyramide PhosphateEQ 100MG BASE · capsule;oral	Disopyramide Phosphate	Rx
Disopyramide PhosphateEQ 150MG BASE · capsule;oral	Disopyramide Phosphate	Rx

All 23 submissions, including labeling and manufacturing supplements


May 7, 2001	Supplement 26Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 27Manufacturing	Approved	None posted
Jan 11, 2001	Supplement 25Labeling	Approved	None posted
Sep 12, 2000	Supplement 23Labeling	Approved	None posted
Sep 12, 2000	Supplement 24Manufacturing	Approved	None posted
Jul 26, 1999	Supplement 22Labeling	Approved	None posted
Mar 3, 1999	Supplement 20Manufacturing	Approved	None posted
Feb 17, 1998	Supplement 18Manufacturing	Approved	None posted
Nov 14, 1997	Supplement 19Manufacturing	Approved	None posted
Oct 23, 1996	Supplement 17Labeling	Approved	None posted
Nov 24, 1992	Supplement 16Labeling	Approved	None posted
Oct 2, 1991	Supplement 15Labeling	Approved	None posted
May 31, 1991	Supplement 13Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 14Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 12Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 9Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 10Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 11Manufacturing	Approved	None posted
Apr 16, 1986	Supplement 5Manufacturing	Approved	None posted
Oct 25, 1985	Supplement 3Manufacturing	Approved	None posted
Jul 24, 1985	Supplement 1Manufacturing	Approved	None posted
Jul 24, 1985	Supplement 2Manufacturing	Approved	None posted
May 31, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70173
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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