Loxitane C

NDA 17658, held by Teva Branded Pharm. Loxapine Hydrochloride.

As of Nov 13, 2026, NDA 17658 (Loxitane C), held by Teva Branded Pharm, was first approved by FDA on May 4, 1976, with 28 approved supplements and 0 published complete response letters.

First approved: May 4, 1976
Review: Standard
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
May 4, 1976	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loxitane CEQ 25MG BASE/ML · concentrate;oral	Loxapine Hydrochloride	Discontinued

All 29 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 22, 2025	Supplement 40Labeling · Standard review	Approved	Letter Label
Jan 22, 2025	Supplement 39Labeling · Standard review	Approved	Letter Label
Feb 23, 2017	Supplement 38Labeling	Approved	Letter Label
Oct 10, 2000	Supplement 36Manufacturing · Standard review	Approved	None posted
Sep 26, 2000	Supplement 37Manufacturing · Standard review	Approved	None posted
Sep 16, 1998	Supplement 35Labeling · Standard review	Approved	None posted
Jan 28, 1998	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 28, 1997	Supplement 33Manufacturing · Standard review	Approved	None posted
Nov 21, 1994	Supplement 32Manufacturing · Standard review	Approved	None posted
Jun 29, 1994	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 29, 1994	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 16, 1990	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 3, 1987	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 30, 1984	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 17, 1983	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 10, 1983	Supplement 18Labeling	Approved	None posted
Sep 13, 1982	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 8, 1981	Supplement 12Labeling	Approved	None posted
May 26, 1981	Supplement 15Manufacturing · Standard review	Approved	None posted
May 14, 1981	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 3, 1981	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 6, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 16, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 24, 1979	Supplement 10Labeling	Approved	None posted
Oct 11, 1977	Supplement 7Labeling	Approved	None posted
Jun 3, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 21, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 21, 1977	Supplement 3Manufacturing · Standard review	Approved	None posted
May 4, 1976	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 17658
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

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