ANDA 70351, held by Sun Pharm Industries. Disopyramide Phosphate.
As of Nov 15, 2026, ANDA 70351 (Disopyramide Phosphate), held by Sun Pharm Industries, was first approved by FDA on Dec 17, 1985, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Disopyramide PhosphateEQ 100MG BASE ยท capsule;oral | Disopyramide Phosphate | Discontinued |
| 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 18Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 20Manufacturing | Approved | None posted |
| Nov 21, 1991 | Supplement 17Labeling | Approved | None posted |
| Sep 30, 1991 | Supplement 16Labeling | Approved | None posted |
| Aug 22, 1990 | Supplement 15Labeling | Approved | None posted |
| Oct 9, 1987 | Supplement 12Manufacturing | Approved | None posted |
| Mar 30, 1987 | Supplement 11Manufacturing | Approved | None posted |
| May 22, 1986 | Supplement 3Manufacturing | Approved | None posted |
| Apr 8, 1986 | Supplement 1Manufacturing | Approved | None posted |
| Apr 8, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Apr 8, 1986 | Supplement 5Manufacturing | Approved | None posted |
| Apr 8, 1986 | Supplement 6Manufacturing | Approved | None posted |
| Dec 17, 1985 | Original application | Approved | None posted |
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
