ANDA 205585, held by Zydus Lifesciences. Piroxicam.
As of Nov 15, 2026, ANDA 205585 (Piroxicam), held by Zydus Lifesciences, was first approved by FDA on Jul 17, 2018, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 17, 2018 | Original application | Approved | None posted |
| Jul 8, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 17, 2018 | 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
