ANDA 78650, held by Halocarbon Prods. Sevoflurane.
As of Nov 15, 2026, ANDA 78650 (Sevoflurane), held by Halocarbon Prods, was first approved by FDA on Nov 19, 2007, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sevoflurane100% · liquid;inhalation | Sevoflurane | 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
