ATRACURIUM BESYLATE PRESERVATIVE FREE
Details
- Status
- Prescription
- First Approved
- 1996-12-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ATRACURIUM BESYLATE PRESERVATIVE FREE Approval History
What ATRACURIUM BESYLATE PRESERVATIVE FREE Treats
11 FDA approvalsOriginally approved for its first indication in 1996 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Dec 1996)
- • Approved indication (Jan 1997)
- • Approved indication (Mar 1997)
- • Approved indication (Mar 1997)
- • Approved indication (Jul 1997)
- • Approved indication (Sep 1997)
- • Approved indication (Jul 1998)Letter
- • Approved indication (Feb 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Apr 2015)
- • Approved indication (Apr 2017)
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.
ATRACURIUM BESYLATE PRESERVATIVE FREE FDA Label Details
ProIndications & Usage
Atracurium Besylate Injection, USP is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.