Disopyramide Phosphate

ANDA 71200, held by Nesher Pharms. Disopyramide Phosphate.

As of Nov 15, 2026, ANDA 71200 (Disopyramide Phosphate), held by Nesher Pharms, was first approved by FDA on Dec 15, 1987, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 15, 1987
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 15, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Disopyramide PhosphateEQ 150MG BASE · capsule, extended release;oral	Disopyramide Phosphate	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Jun 12, 2002	Supplement 23Labeling	Approved	None posted
Jun 12, 2002	Supplement 21Manufacturing	Approved	None posted
Jun 12, 2002	Supplement 20Manufacturing	Approved	None posted
Jun 12, 2002	Supplement 19Manufacturing	Approved	None posted
Jun 12, 2002	Supplement 18Manufacturing	Approved	None posted
Oct 26, 2000	Supplement 16Manufacturing	Approved	None posted
Oct 25, 2000	Supplement 17Labeling	Approved	None posted
Apr 5, 1999	Supplement 15Manufacturing	Approved	None posted
Oct 6, 1998	Supplement 13Manufacturing	Approved	None posted
Nov 25, 1996	Supplement 14Labeling	Approved	None posted
Feb 25, 1993	Supplement 9Manufacturing	Approved	None posted
Jan 14, 1993	Supplement 12Labeling	Approved	None posted
Oct 7, 1992	Supplement 11Labeling	Approved	None posted
Apr 30, 1992	Supplement 10Labeling	Approved	None posted
Dec 9, 1991	Supplement 5Manufacturing	Approved	None posted
Oct 23, 1991	Supplement 8Labeling	Approved	None posted
May 21, 1991	Supplement 4Manufacturing	Approved	None posted
Feb 2, 1990	Supplement 2Labeling	Approved	None posted
Jan 29, 1990	Supplement 3Manufacturing	Approved	None posted
Dec 15, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71200
Drugs@FDA: Overview at FDA
Company: Nesher 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