Manages pain severe enough to require an opioid analgesic. ANDA 205758, held by Hikma. Morphine Sulfate.
As of Nov 15, 2026, ANDA 205758 (Morphine Sulfate), held by Hikma, was first approved by FDA on May 21, 2015, 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 |
|---|---|---|---|
| May 21, 2015 | Original application | Approved |
| Morphine Sulfate4MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Morphine Sulfate8MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Morphine Sulfate10MG/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
