ANDA 70618, held by Copley Pharm. Potassium Chloride.
As of Nov 15, 2026, ANDA 70618 (Potassium Chloride), held by Copley Pharm, was first approved by FDA on Sep 9, 1987, with 19 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Chloride8MEQ ยท tablet, extended release;oral | Potassium Chloride | Discontinued |
| Jan 23, 2006 | Supplement 22Labeling | Approved | None posted |
| Apr 14, 2005 | Supplement 21Labeling | Approved | None posted |
| Jul 18, 2002 | Supplement 17Manufacturing | Approved | None posted |
| Jul 18, 2002 | Supplement 15Manufacturing | Approved | None posted |
| Jul 18, 2002 | Supplement 14Manufacturing | Approved | None posted |
| Jul 18, 2002 | Supplement 13Manufacturing | Approved | None posted |
| Apr 10, 2002 | Supplement 16Manufacturing | Approved | None posted |
| Jan 23, 2002 | Supplement 9Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Oct 31, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Apr 2, 2001 | Supplement 8Manufacturing | Approved | None posted |
| Jun 17, 1999 | Supplement 7Manufacturing | Approved | None posted |
| Mar 23, 1999 | Supplement 6Manufacturing | Approved | None posted |
| Jun 11, 1998 | Supplement 5Manufacturing | Approved | None posted |
| Dec 12, 1996 | Supplement 4Manufacturing | Approved | None posted |
| May 31, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Feb 27, 1992 | Supplement 2Manufacturing | Approved | None posted |
| Mar 17, 1989 | Supplement 1Labeling | Approved | None posted |
| Sep 9, 1987 | 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
