ANDA 200824, held by Rising. Morphine Sulfate.
As of Nov 15, 2026, ANDA 200824 (Morphine Sulfate), held by Rising, was first approved by FDA on Oct 18, 2011, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 2011 | Original application | Approved |
| Morphine Sulfate15MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate30MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate60MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate100MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate200MG · tablet, extended release;oral | Morphine Sulfate | Discontinued |
| Jun 18, 2026 | Supplement 23REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 21REMS | Approved | None posted |
| Sep 18, 2018 | Supplement 17REMS | Approved | None posted |
| May 26, 2017 | Supplement 16REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 14REMS | Approved | None posted |
| Apr 20, 2016 | Supplement 13REMS | Approved | None posted |
| Jun 26, 2015 | Supplement 12REMS | Approved | None posted |
| Aug 19, 2014 | Supplement 8REMS | Approved | None posted |
| Jun 25, 2014 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 15, 2013 | Supplement 4REMS | Approved | None posted |
| Jul 9, 2012 | Supplement 3REMS | Approved | None posted |
| Jul 9, 2012 | Supplement 2Labeling | Approved | None posted |
| Oct 18, 2011 | 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
