Navane

As of Nov 13, 2026, NDA 16584 (Navane), held by Pfizer, was first approved by FDA on Jul 24, 1967, with 28 approved supplements and 0 published complete response letters.

First approved: Jul 24, 1967
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
Jul 24, 1967	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

5 strengths and forms


Navane1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Thiothixene	DiscontinuedReference drug
Navane2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Thiothixene	DiscontinuedReference drug
Navane5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Thiothixene	DiscontinuedReference drug
Navane10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Thiothixene	DiscontinuedReference drug
Navane20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Thiothixene	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements


Dec 1, 2010	Supplement 60Labeling	Approved	Letter Label
Jul 19, 2009	Supplement 59Labeling	Approved	Letter Label
Aug 14, 2008	Supplement 58Labeling · Standard review	Approved	Label Letter
Apr 7, 2008	Supplement 57Labeling · Standard review	Approved	Label Letter
May 19, 2003	Supplement 56Labeling · Standard review	Approved	Label
Jul 31, 2001	Supplement 55Labeling · Standard review	Approved	Letter
Jul 31, 2001	Supplement 47Labeling · Standard review	Approved	Label Letter
Feb 28, 2001	Supplement 54Manufacturing · Standard review	Approved	None posted
Mar 27, 2000	Supplement 52Manufacturing · Standard review	Approved	None posted
Jul 26, 1994	Supplement 51Manufacturing · Standard review	Approved	None posted
Jun 26, 1984	Supplement 45Manufacturing · Standard review	Approved	None posted
Jun 21, 1984	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 10, 1982	Supplement 42Manufacturing · Standard review	Approved	None posted
Sep 24, 1982	Supplement 37Manufacturing · Standard review	Approved	None posted
May 21, 1981	Supplement 39Manufacturing · Standard review	Approved	None posted
Mar 10, 1981	Supplement 38Manufacturing · Standard review	Approved	None posted
Dec 10, 1980	Supplement 36Labeling	Approved	None posted
Oct 8, 1980	Supplement 35Manufacturing · Standard review	Approved	None posted
Sep 15, 1980	Supplement 34Manufacturing · Standard review	Approved	None posted
Oct 3, 1979	Supplement 33Manufacturing · Standard review	Approved	None posted
Dec 11, 1978	Supplement 30Manufacturing · Standard review	Approved	None posted
Dec 8, 1978	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 7, 1978	Supplement 28Labeling	Approved	None posted
Jul 7, 1978	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 18, 1977	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 29, 1976	Supplement 23Manufacturing · Standard review	Approved	None posted
May 1, 1975	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 24, 1974	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 24, 1967	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 16584
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