Disopyramide Phosphate

ANDA 70186, held by Ivax Sub Teva Pharms. Disopyramide Phosphate.

As of Nov 15, 2026, ANDA 70186 (Disopyramide Phosphate), held by Ivax Sub Teva Pharms, was first approved by FDA on Nov 18, 1985, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 18, 1985
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
Nov 18, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Disopyramide PhosphateEQ 100MG BASE · capsule;oral	Disopyramide Phosphate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Apr 22, 1992	Supplement 6Labeling	Approved	None posted
Oct 11, 1991	Supplement 5Labeling	Approved	None posted
Jun 10, 1988	Supplement 3Labeling	Approved	None posted
Sep 9, 1987	Supplement 1Manufacturing	Approved	None posted
Sep 9, 1987	Supplement 2Manufacturing	Approved	None posted
Nov 18, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70186
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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