For acute pain severe enough to require an opioid analgesic. ANDA 212451, held by Alkem Labs Ltd. Morphine Sulfate.
As of Nov 15, 2026, ANDA 212451 (Morphine Sulfate), held by Alkem Labs Ltd, was first approved by FDA on Dec 3, 2020, with 2 approved supplements and 0 published complete response letters.
Morphine sulfate tablets are indicated for the management of: adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration,, reserve morphine sulfate tablets for use in patients for whom alternative treatment options (e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 3, 2020 | Original application | Approved |
| Morphine Sulfate15MG · tablet;oral | Morphine Sulfate | Rx |
| Morphine Sulfate30MG · tablet;oral | Morphine Sulfate | Rx |
| Jun 18, 2026 | Supplement 7REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 4REMS | Approved | None posted |
| Dec 3, 2020 | 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
