ANDA 211454, held by Winder Labs LLC. Morphine Sulfate.
As of Nov 15, 2026, ANDA 211454 (Morphine Sulfate), held by Winder Labs LLC, was first approved by FDA on Feb 12, 2021, with 3 approved supplements and 0 published complete response letters.
Morphine Sulfate Oral Solution 2 mg/mL and 4 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. Morphine Sulfate Oral Solution is an opioid agonist.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2021 | Original application | Approved |
| Morphine Sulfate10MG/5ML · solution;oral | Morphine Sulfate | Rx |
| Morphine Sulfate20MG/5ML · solution;oral | Morphine Sulfate | Rx |
| Morphine Sulfate100MG/5ML · solution;oral | Morphine Sulfate | Rx |
| Jun 18, 2026 | Supplement 4REMS | Approved | None posted |
| Apr 30, 2025 | Supplement 3REMS | Approved | None posted |
| Feb 16, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 12, 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
