Navane

NDA 16758, held by Pfizer. Thiothixene Hydrochloride.

As of Nov 13, 2026, NDA 16758 (Navane), held by Pfizer, was first approved by FDA on Apr 6, 1970, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 6, 1970
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 6, 1970	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
NavaneEQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · concentrate;oral	Thiothixene Hydrochloride	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 19, 2009	Supplement 20Labeling · Standard review	Approved	Label Letter
Apr 7, 2008	Supplement 19Labeling · Standard review	Approved	Letter Label
May 19, 2003	Supplement 17Labeling · Standard review	Approved	Label
Jul 31, 2001	Supplement 11Labeling · Standard review	Approved	Letter
Jul 31, 2001	Supplement 16Labeling · Standard review	Approved	Letter
Dec 10, 1980	Supplement 7Labeling	Approved	None posted
May 1, 1975	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 6, 1970	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 16758
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