Manages severe and persistent pain. ANDA 203158, held by Anda Repository. Morphine Sulfate.
As of Nov 15, 2026, ANDA 203158 (Morphine Sulfate), held by Anda Repository, was first approved by FDA on Aug 4, 2021, with 5 approved supplements and 0 published complete response letters.
Morphine Sulfate Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2021 | Original application | Approved |
| Morphine Sulfate20MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate30MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate50MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate60MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate80MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate100MG · capsule, extended release;oral | Morphine Sulfate | Discontinued |
| Dec 22, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 9, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 4REMS | Approved | None posted |
| Dec 15, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 4, 2021 | 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
