ANDA 77938, held by Puracap Pharm. Meloxicam.
As of Nov 14, 2026, ANDA 77938 (Meloxicam), held by Puracap Pharm, was first approved by FDA on Jul 19, 2006, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2006 | Original application | Approved |
| Dec 16, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 12, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 13, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 19, 2006 | Original application | Approved |
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
