Manages pain severe enough to require an opioid analgesic. ANDA 211452, held by Hikma. Morphine Sulfate.
As of Nov 15, 2026, ANDA 211452 (Morphine Sulfate), held by Hikma, was first approved by FDA on Jan 12, 2023, with 0 approved supplements and 0 published complete response letters.
Morphine Sulfate Injection, is indicated for the management of 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2023 | Original application | Approved |
| Morphine Sulfate2MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Morphine Sulfate4MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Morphine Sulfate8MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Morphine Sulfate10MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Morphine Sulfate15MG/ML · injectable;injection | Morphine Sulfate | Rx |
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
