SUFENTANIL CITRATE · Hikma
SUFENTANIL CITRATE is FDA-approved to treat 1 condition (same as SUFENTA PRESERVATIVE FREE).
Details
- Status
- Prescription
- First Approved
- 1984-05-04
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SUFENTANIL CITRATE Approval History
What SUFENTANIL CITRATE Treats
1 indicationsSUFENTANIL CITRATE is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Labor Pain
Same approved indications as SUFENTA PRESERVATIVE FREE (same active ingredient).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06530563 | XiangyaHMZK | Ph 4 | not yet recruiting | the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery |
| NCT05831345 | CHUB-Methadone | Ph 3 | recruiting | Intraoperative Methadone for the Prevention of Postoperative Pain |
| NCT03685188 | WCH2018086 | Ph 4 | enrolling by invitation | Oxycodone and Sufentanil for Analgesia in Hip Surgery |
| NCT00738192 CARAN | NMU-FY2008-311 NJFY0807311M | Ph 4 | completed | Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUFENTANIL CITRATE FDA Label Details
Indications & Usage
SUFENTANIL CITRATE is FDA-approved to treat 1 condition — same approved indications as SUFENTA PRESERVATIVE FREE.
Looking for the branded version?
SUFENTA PRESERVATIVE FREE
Full clinical data, patents, trials, and competitive landscape for sufentanil citrate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.