ANDA 74416, held by Piramal Critical. Isoflurane.
As of Nov 15, 2026, ANDA 74416 (Isoflurane), held by Piramal Critical, was first approved by FDA on Sep 30, 1994, with 9 approved supplements and 0 published complete response letters.
Isoflurane USP may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. Isoflurane USP, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 1994 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isoflurane99.9% · liquid;inhalation | Isoflurane | Rx |
| Jan 8, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jan 8, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 8, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 8, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 6, 2015 | Supplement 7Labeling | Approved | None posted |
| Jun 7, 2000 | Supplement 4Manufacturing | Approved | None posted |
| Jun 7, 2000 | Supplement 3Labeling | Approved | None posted |
| Jan 3, 2000 | Supplement 5Manufacturing | Approved | None posted |
| Aug 15, 1996 | Supplement 1Labeling | Approved | None posted |
| Sep 30, 1994 | Original application | Approved | None posted |
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
