ANDA 75225, held by Halocarbon Prods. Isoflurane.
As of Nov 15, 2026, ANDA 75225 (Isoflurane), held by Halocarbon Prods, was first approved by FDA on Oct 20, 1999, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Isoflurane may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isoflurane99.9% · liquid;inhalation | Isoflurane | Rx |
| Sep 23, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 20, 1999 | Original application | Approved |
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
