ANDA 203518, held by Tris Pharma Inc. Morphine Sulfate.
As of Nov 15, 2026, ANDA 203518 (Morphine Sulfate), held by Tris Pharma Inc, was first approved by FDA on May 12, 2015, with 3 approved supplements and 0 published complete response letters.
Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of: adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2015 | Original application | Approved |
| Morphine Sulfate10MG/5ML · solution;oral | Morphine Sulfate | Discontinued |
| Morphine Sulfate100MG/5ML · solution;oral | Morphine Sulfate | Rx |
| Jun 18, 2026 | Supplement 21REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 17REMS | Approved | None posted |
| Sep 18, 2018 | Supplement 4REMS · Standard review | Approved | None posted |
| May 12, 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
