NDA 17525, held by Teva Branded Pharm. Loxapine Succinate.
As of Nov 13, 2026, NDA 17525 (Loxitane), held by Teva Branded Pharm, was first approved by FDA on Feb 25, 1975, with 36 approved supplements and 0 published complete response letters.
| Mar 10, 1983 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Feb 25, 1975 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| LoxitaneEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Loxapine Succinate | DiscontinuedReference drug |
| LoxitaneEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Loxapine Succinate | DiscontinuedReference drug |
| LoxitaneEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Loxapine Succinate | DiscontinuedReference drug |
| LoxitaneEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Loxapine Succinate | DiscontinuedReference drug |
| LoxitaneEQ 10MG BASE **Federal Register determination that product was discontinued or withdrawn for s or e reasons** · tablet;oral | Loxapine Succinate | DiscontinuedReference drug |
| LoxitaneEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Loxapine Succinate | DiscontinuedReference drug |
| LoxitaneEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Loxapine Succinate | DiscontinuedReference drug |
| Jan 22, 2025 | Supplement 53Labeling · Standard review | Approved | |
| Jan 22, 2025 | Supplement 52Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 51Labeling | Approved | |
| Sep 16, 1998 | Supplement 49Labeling · Standard review | Approved | None posted |
| Jan 28, 1997 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1996 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1995 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jun 29, 1994 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Mar 29, 1994 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Dec 16, 1991 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1990 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1989 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Apr 28, 1989 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1987 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| May 2, 1986 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| May 14, 1985 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1983 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Apr 19, 1983 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 10, 1983 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Sep 13, 1982 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Oct 8, 1981 | Supplement 20Labeling | Approved | None posted |
| Oct 8, 1981 | Supplement 19Labeling | Approved | None posted |
| Jan 6, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1980 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1979 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1979 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1978 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1978 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1978 | Supplement 12Labeling | Approved | None posted |
| Oct 25, 1977 | Supplement 8Labeling | Approved | None posted |
| Jun 3, 1977 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1976 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 23, 1976 | Supplement 9Labeling | Approved | None posted |
| May 4, 1976 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 4, 1976 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 4, 1976 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1975 | Original applicationNew molecular entity · 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
