ROBINUL
Details
- Status
- Prescription
- First Approved
- 1961-08-11
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
ROBINUL Approval History
What ROBINUL Treats
3 indicationsROBINUL is approved for 3 conditions since its original approval in 1961. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Excessive Secretions
- Arrhythmia
- Peptic Ulcer
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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.
ROBINUL FDA Label Details
ProIndications & Usage
FDA Label (PDF)In Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents s...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.