ANDA 74110, held by Hamilton Pharms. Naproxen.
As of Nov 14, 2026, ANDA 74110 (Naproxen), held by Hamilton Pharms, was first approved by FDA on Oct 30, 1992, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 1992 | Original application | Approved | None posted |
| Dec 28, 1995 | Supplement 5Labeling | Approved | None posted |
| Feb 17, 1995 | Supplement 2Labeling | Approved | None posted |
| Oct 30, 1992 | 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
