NDA 19977, held by Xanodyne Pharms Inc. Morphine Sulfate.
As of Nov 13, 2026, NDA 19977 (Oramorph Sr), held by Xanodyne Pharms Inc, was first approved by FDA on Aug 15, 1991, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 1991 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oramorph Sr30MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Oramorph Sr60MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Oramorph Sr100MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Oramorph Sr15MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2001 | Supplement 4Labeling · Standard review | Approved | |
| Jul 13, 2001 | Supplement 7Labeling · Standard review | Approved | |
| Nov 23, 1994 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 18, 1994 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1994 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1991 | Original applicationNew formulation or manufacturer · Standard review | 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
