approval · primary record
HYDROMORPHONE HYDROCHLORIDE
2 approval events · latest 2026-06-18
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-06-18 |
| Approval events | 2 |
| Brand | DILAUDID |
| Sponsor | RHODES PHARMS |
| Route | ORAL |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-06-18 | FDA | NDA | DILAUDID | RHODES PHARMS | ORAL |
| 2025-12-22 | FDA | NDA | HYDROMORPHONE HYDROCHLORIDE | HIKMA | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:31:19.254Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:hydromorphone-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Hydromorphone Hydrochloride · compound