Disopyramide Phosphate

ANDA 70470, held by Rising. Disopyramide Phosphate.

As of Nov 15, 2026, ANDA 70470 (Disopyramide Phosphate), held by Rising, was first approved by FDA on Dec 10, 1985, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1985
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 10, 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 14 submissions, including labeling and manufacturing supplements


Aug 11, 1997	Supplement 14Manufacturing	Approved	None posted
Feb 23, 1995	Supplement 13Manufacturing	Approved	None posted
Jun 21, 1993	Supplement 12Labeling	Approved	None posted
Apr 7, 1993	Supplement 11Labeling	Approved	None posted
Feb 18, 1992	Supplement 10Labeling	Approved	None posted
Sep 9, 1991	Supplement 9Labeling	Approved	None posted
Dec 27, 1990	Supplement 8Labeling	Approved	None posted
Nov 1, 1988	Supplement 6Manufacturing	Approved	None posted
Nov 1, 1988	Supplement 7Manufacturing	Approved	None posted
Mar 9, 1988	Supplement 5Labeling	Approved	None posted
Mar 3, 1987	Supplement 1Manufacturing	Approved	None posted
Mar 3, 1987	Supplement 2Manufacturing	Approved	None posted
Mar 3, 1987	Supplement 3Manufacturing	Approved	None posted
Dec 10, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70470
Drugs@FDA: Overview at FDA
Company: Rising 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