Manages pain severe enough to require an opioid analgesic. NDA 217812, held by Hikma. Hydromorphone Hydrochloride.
As of Nov 13, 2026, NDA 217812 (Hydromorphone Hydrochloride), held by Hikma, was first approved by FDA on Dec 14, 2023, with 1 approved supplement and 0 published complete response letters.
Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride 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 |
|---|---|---|---|
| Dec 14, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydromorphone Hydrochloride40MG/20ML (2MG/ML) · solution;intramuscular, intravenous, subcutaneous | Hydromorphone Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Dec 14, 2023 | Original applicationNew formulation or manufacturer · Standard review | 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
