Disopyramide Phosphate

ANDA 70352, held by Sun Pharm Industries. Disopyramide Phosphate.

As of Nov 15, 2026, ANDA 70352 (Disopyramide Phosphate), held by Sun Pharm Industries, was first approved by FDA on Dec 17, 1985, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1985
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Dec 17, 1985	Original application	Approved	None posted

Products

1 strengths and forms

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

All 21 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 24Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 23Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 22Manufacturing	Approved	None posted
Oct 15, 1992	Supplement 21Labeling	Approved	None posted
Apr 3, 1992	Supplement 20Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 18Manufacturing	Approved	None posted
Nov 21, 1991	Supplement 17Labeling	Approved	None posted
Sep 30, 1991	Supplement 16Labeling	Approved	None posted
Aug 22, 1990	Supplement 25Labeling	Approved	None posted
Aug 22, 1990	Supplement 15Labeling	Approved	None posted
Dec 1, 1987	Supplement 12Manufacturing	Approved	None posted
Dec 1, 1987	Supplement 11Manufacturing	Approved	None posted
Apr 1, 1987	Supplement 13Manufacturing	Approved	None posted
May 22, 1986	Supplement 10Manufacturing	Approved	None posted
May 22, 1986	Supplement 9Manufacturing	Approved	None posted
May 22, 1986	Supplement 3Manufacturing	Approved	None posted
Apr 8, 1986	Supplement 6Manufacturing	Approved	None posted
Apr 8, 1986	Supplement 5Manufacturing	Approved	None posted
Apr 8, 1986	Supplement 2Manufacturing	Approved	None posted
Apr 8, 1986	Supplement 1Manufacturing	Approved	None posted
Dec 17, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70352
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