Navane

NDA 16904, held by Pfizer. Thiothixene Hydrochloride.

As of Nov 14, 2026, NDA 16904 (Navane), held by Pfizer, was first approved by FDA on Aug 19, 1971, with 17 approved supplements and 0 published complete response letters.

First approved: Aug 19, 1971
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Aug 19, 1971	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

2 strengths and forms


NavaneEQ 2MG BASE/ML · injectable;injection	Thiothixene Hydrochloride	Discontinued
NavaneEQ 10MG BASE/VIAL · injectable;injection	Thiothixene Hydrochloride	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Jul 19, 2009	Supplement 34Labeling · Standard review	Approved	Label Letter
Apr 7, 2008	Supplement 33Labeling · Standard review	Approved	Letter Label
Aug 2, 1996	Supplement 31Manufacturing · Standard review	Approved	None posted
Jul 25, 1996	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 15, 1994	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 19, 1989	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 10, 1987	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 26, 1985	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 10, 1984	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 17, 1984	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 8, 1983	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 18, 1982	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 18, 1982	Supplement 14Labeling	Approved	None posted
Jun 2, 1981	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 10, 1980	Supplement 11Labeling	Approved	None posted
Oct 12, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 21, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 19, 1971	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 16904
Drugs@FDA: Overview at FDA
Company: Pfizer

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