NDA 18039, held by Actavis Labs Ut Inc. Loxapine Hydrochloride.
As of Nov 13, 2026, NDA 18039 (Loxitane Im), held by Actavis Labs Ut Inc, was first approved by FDA on Oct 26, 1979, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 26, 1979 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loxitane ImEQ 50MG BASE/ML · injectable;injection | Loxapine Hydrochloride | Discontinued |
| Feb 23, 2017 | Supplement 24Labeling | Approved | |
| Sep 16, 1998 | Supplement 23Labeling · Standard review | Approved | None posted |
| Nov 21, 1994 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1994 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1994 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1987 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1984 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1983 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 10, 1983 | Supplement 7Labeling | Approved | None posted |
| Oct 8, 1981 | Supplement 5Labeling | Approved | None posted |
| Jan 6, 1981 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1980 | Supplement 2Labeling | Approved | None posted |
| Sep 16, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 20, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1979 | Original applicationNew dosage form · Standard review | 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
