ANDA 77339, held by L Perrigo Co. Naproxen.
As of Nov 14, 2026, ANDA 77339 (Naproxen), held by L Perrigo Co, was first approved by FDA on Apr 27, 2005, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2005 | Original application | Approved | None posted |
| Apr 29, 2009 | Supplement 6Labeling | Approved | None posted |
| Jun 15, 2006 | Supplement 2Labeling | Approved | None posted |
| Feb 17, 2006 | Supplement 1Labeling | Approved | None posted |
| Apr 27, 2005 | 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
