ANDA 74162, held by Sandoz. Naproxen Sodium.
As of Nov 15, 2026, ANDA 74162 (Naproxen Sodium), held by Sandoz, was first approved by FDA on Dec 21, 1993, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 1993 | Original application | Approved | None posted |
| Naproxen SodiumEQ 250MG BASE · tablet;oral | Naproxen Sodium | Discontinued |
| Naproxen SodiumEQ 500MG BASE · tablet;oral | Naproxen Sodium | Discontinued |
| Apr 19, 2002 | Supplement 16Manufacturing | Approved | None posted |
| Aug 29, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Aug 8, 2001 | Supplement 14Manufacturing | Approved | None posted |
| May 9, 2001 | Supplement 15Manufacturing | Approved | None posted |
| Apr 26, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Jan 4, 2001 | Supplement 12Manufacturing | Approved | None posted |
| May 5, 1999 | Supplement 10Manufacturing | Approved | None posted |
| Mar 4, 1999 | Supplement 6Manufacturing | Approved | None posted |
| Mar 4, 1999 | Supplement 7Labeling | Approved | None posted |
| Jun 29, 1998 | Supplement 9Manufacturing | Approved | None posted |
| Mar 9, 1998 | Supplement 8Labeling | Approved | None posted |
| Feb 4, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Nov 10, 1997 | Supplement 5Labeling | Approved | None posted |
| Oct 17, 1997 | Supplement 2Manufacturing | Approved | None posted |
| Oct 17, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Feb 27, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Dec 21, 1993 | 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
