ROPIVACAINE HYDROCHLORIDE
Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.
Details
- Status
- Prescription
- First Approved
- 2014-07-17
- Routes
- INJECTION
- Dosage Forms
- SOLUTION, INJECTABLE
Companies
ROPIVACAINE HYDROCHLORIDE Approval History
What ROPIVACAINE HYDROCHLORIDE Treats
15 FDA approvalsOriginally approved for its first indication in 2014 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Jul 2014)
- • Approved indication (Sep 2014)
- • Approved indication (Apr 2016)Letter
- • Approved indication (Jul 2016)Label Letter
- • Approved indication (Mar 2018)Letter
- • Approved indication (Jun 2018)Letter
- • Approved indication (Jun 2018)
- • Approved indication (Apr 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Aug 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Oct 2023)
- • Approved indication (Jul 2024)
- • Approved indication (Aug 2024)
- • Approved indication (Mar 2025)
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07519109 | SYH9089-001 | Ph 1 | not yet recruiting | Study Evaluating the Safety, Efficacy and Pharmacokinetics of SYH9089 Injection in Patients Undergoing Abdominal Surgery. |
| NCT07353307 | TRD303-Ⅲ -02 | Ph 3 | recruiting | A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Profile of TRD303 for Postoperative Analgesia After Abdominal Surgery in China. |
| NCT03360214 results posted | AAAQ4708 | Ph 4 | completed | PEMF and PEC Blocks in Mastectomy Reconstruction Patients |
| NCT04368364 results posted | HSC-MS-20-0143 | Ph 4 | terminated | A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain |
| NCT02438852 | 4B-14-4 NCI-2015-00279, 4B-14-4 | Ph 3 | withdrawn | Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer |
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.
ROPIVACAINE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration Ropivacaine Hydrochloride is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery...
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NAROPIN
Full clinical data, patents, trials, and competitive landscape for ropivacaine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.