ANDA 203849, held by Actavis Elizabeth. Morphine Sulfate.
As of Nov 15, 2026, ANDA 203849 (Morphine Sulfate), held by Actavis Elizabeth, was first approved by FDA on Apr 6, 2015, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 6, 2015 | 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 28REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 25REMS | Approved | None posted |
| Sep 18, 2018 | Supplement 15REMS | Approved | None posted |
| May 26, 2017 | Supplement 11REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 7REMS | Approved | None posted |
| Apr 20, 2016 | Supplement 4REMS | Approved | None posted |
| Jun 26, 2015 | Supplement 1REMS | Approved | None posted |
| Apr 6, 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
