ANDA 72274, held by Ani Pharms. Fenoprofen Calcium.
As of Nov 15, 2026, ANDA 72274 (Fenoprofen Calcium), held by Ani Pharms, was first approved by FDA on May 2, 1988, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 1988 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fenoprofen CalciumEQ 600MG BASE · tablet;oral | Fenoprofen Calcium | Discontinued |
| Nov 21, 2024 | Supplement 26Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 25Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 24Labeling · Standard review | Approved | None posted |
| Feb 18, 2016 | Supplement 23Labeling · Standard review | Approved | None posted |
| Mar 8, 2002 | Supplement 14Labeling | Approved | None posted |
| Feb 26, 2002 | Supplement 13Manufacturing | Approved | None posted |
| Nov 2, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Sep 7, 1999 | Supplement 11Manufacturing | Approved | None posted |
| Jan 18, 1996 | Supplement 10Manufacturing | Approved | None posted |
| May 13, 1994 | Supplement 9Manufacturing | Approved | None posted |
| Jul 29, 1991 | Supplement 4Manufacturing | Approved | None posted |
| Jul 22, 1991 | Supplement 8Labeling | Approved | None posted |
| Jan 4, 1989 | Supplement 2Manufacturing | Approved | None posted |
| Jan 4, 1989 | Supplement 1Manufacturing | Approved | None posted |
| May 2, 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
