ANDA 74661, held by Perrigo. Naproxen Sodium.
As of Nov 15, 2026, ANDA 74661 (Naproxen Sodium), held by Perrigo, was first approved by FDA on Jan 13, 1997, with 15 approved supplements and 0 published complete response letters.
Uses
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 13, 1997 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naproxen Sodium220MG · tablet;oral | Naproxen Sodium | OTC |
| Nov 12, 2014 | Supplement 40Labeling | Approved | None posted |
| Oct 25, 2014 | Supplement 54Labeling · Standard review | Approved | None posted |
| Oct 25, 2014 | Supplement 58Labeling · Standard review | Approved | None posted |
| Oct 25, 2014 | Supplement 62Labeling · Standard review | Approved | None posted |
| Jan 19, 2012 | Supplement 44Labeling | Approved | None posted |
| Sep 7, 2010 | Supplement 43Labeling | Approved | None posted |
| Dec 19, 2006 | Supplement 28Labeling | Approved | None posted |
| Mar 13, 2006 | Supplement 27Labeling | Approved | None posted |
| Nov 20, 2002 | Supplement 9Manufacturing | Approved | None posted |
| Nov 20, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Dec 10, 2001 | Supplement 8Labeling | Approved | None posted |
| Aug 25, 1999 | Supplement 5Manufacturing | Approved | None posted |
| Feb 19, 1999 | Supplement 4Labeling | Approved | None posted |
| Aug 28, 1998 | Supplement 3Manufacturing | Approved | None posted |
| Aug 11, 1997 | Supplement 1Manufacturing | Approved | None posted |
| Jan 13, 1997 | 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
