Manages pain severe enough to require use of an opioid analgesic. ANDA 202861, held by Intl Medication Sys. Morphine Sulfate.
As of Nov 15, 2026, ANDA 202861 (Morphine Sulfate), held by Intl Medication Sys, was first approved by FDA on Apr 29, 2021, with 3 approved supplements and 0 published complete response letters.
Morphine Sulfate Injection is indicated for the management of pain severe enough to require use of an opioid analgesic by Patient Controlled Analgesia (PCA), and for which alternative treatments are inadequate. Limitations of Use Preservative-free Morphine Sulfate Injection is for administration via a compatible Alaris infusion device.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Morphine Sulfate1MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Dec 22, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 22, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 29, 2021 | Original application | Approved | None posted |
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
