For acute pain severe enough to require an opioid analgesic. ANDA 215194, held by Specgx LLC. Morphine Sulfate.
As of Nov 15, 2026, ANDA 215194 (Morphine Sulfate), held by Specgx LLC, was first approved by FDA on Aug 21, 2023, with 2 approved supplements and 0 published complete response letters.
Morphine Sulfate Tablets are indicated for the management of: adults 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 |
|---|---|---|---|
| Aug 21, 2023 | Original application | Approved |
| Morphine Sulfate15MG · tablet;oral | Morphine Sulfate | Rx |
| Morphine Sulfate30MG · tablet;oral | Morphine Sulfate | Rx |
| Jun 18, 2026 | Supplement 4REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 1REMS | Approved | None posted |
| Aug 21, 2023 | 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
