ANDA 72267, held by Pharmaco. Fenoprofen Calcium.
As of Nov 15, 2026, ANDA 72267 (Fenoprofen Calcium), held by Pharmaco, was first approved by FDA on Jun 8, 1988, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 1988 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fenoprofen CalciumEQ 600MG BASE · tablet;oral | Fenoprofen Calcium | Discontinued |
| Nov 21, 2024 | Supplement 27Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 25Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 23Labeling · Standard review | Approved | None posted |
| Apr 24, 2015 | Supplement 22Labeling · Standard review | Approved | None posted |
| Dec 20, 2007 | Supplement 19Labeling | Approved | None posted |
| May 16, 2006 | Supplement 16Labeling | Approved | None posted |
| Mar 13, 2006 | Supplement 15Labeling | Approved | None posted |
| Jun 26, 1998 | Supplement 13Manufacturing | Approved | None posted |
| Feb 5, 1998 | Supplement 14Manufacturing | Approved | None posted |
| Mar 4, 1997 | Supplement 12Manufacturing | Approved | None posted |
| Oct 31, 1991 | Supplement 8Labeling | Approved | None posted |
| Oct 31, 1991 | Supplement 7Manufacturing | Approved | None posted |
| Oct 9, 1991 | Supplement 9Labeling | Approved | None posted |
| Jan 31, 1990 | Supplement 5Manufacturing | Approved | None posted |
| Aug 11, 1988 | Supplement 3Labeling | Approved | None posted |
| Jun 8, 1988 | 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
