ANDA 203506, held by Sun Pharm Inds Ltd. Oxymorphone Hydrochloride.
As of Nov 15, 2026, ANDA 203506 (Oxymorphone Hydrochloride), held by Sun Pharm Inds Ltd, was first approved by FDA on Apr 24, 2015, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2015 | Original application | Approved |
| Oxymorphone Hydrochloride5MG · tablet, extended release;oral | Oxymorphone Hydrochloride | Discontinued |
| Oxymorphone Hydrochloride7.5MG · tablet, extended release;oral | Oxymorphone Hydrochloride | Discontinued |
| Oxymorphone Hydrochloride10MG · tablet, extended release;oral | Oxymorphone Hydrochloride | Discontinued |
| Oxymorphone Hydrochloride15MG · tablet, extended release;oral | Oxymorphone Hydrochloride | Discontinued |
| Oxymorphone Hydrochloride20MG · tablet, extended release;oral | Oxymorphone Hydrochloride | Discontinued |
| Oxymorphone Hydrochloride30MG · tablet, extended release;oral | Oxymorphone Hydrochloride | Discontinued |
| Oxymorphone Hydrochloride40MG · tablet, extended release;oral | Oxymorphone Hydrochloride | Discontinued |
| May 26, 2017 | Supplement 7REMS | Approved | None posted |
| Dec 16, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 16, 2016 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 30, 2016 | Supplement 4REMS | Approved | None posted |
| Apr 20, 2016 | Supplement 2REMS | Approved | None posted |
| Jun 26, 2015 | Supplement 1REMS | Approved | None posted |
| Apr 24, 2015 | 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
