Manages severe and persistent pain. ANDA 203602, held by Novel Labs Inc. Morphine Sulfate.
As of Nov 15, 2026, ANDA 203602 (Morphine Sulfate), held by Novel Labs Inc, was first approved by FDA on Dec 16, 2015, with 11 approved supplements and 0 published complete response letters.
Morphine sulfate extended-release tablets is an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve morphine sulfate extended-release tablets for use in patients for whom alternative treatment options (e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 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 12REMS | Approved | None posted |
| Feb 3, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 3, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 3, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 3, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 3, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 10REMS | Approved | None posted |
| Sep 18, 2018 | Supplement 7REMS | Approved | None posted |
| May 26, 2017 | Supplement 6REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 4REMS | Approved | None posted |
| Apr 20, 2016 | Supplement 1REMS | Approved | None posted |
| Dec 16, 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
