Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age. Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age. Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients. Sedation for Adult Patients in Combination with Regional Anesthesia. Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propofol10MG/ML · injectable;injection | Propofol | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
