Prolixin Enanthate

NDA 16110, held by Apothecon. Fluphenazine Enanthate.

As of Nov 13, 2026, NDA 16110 (Prolixin Enanthate), held by Apothecon, was first approved by FDA on Mar 15, 1967, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 15, 1967
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Mar 15, 1967	Original applicationNew active ingredient · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prolixin Enanthate25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Fluphenazine Enanthate	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Jan 21, 1992	Supplement 37Manufacturing · Priority review	Approved	None posted
Apr 26, 1989	Supplement 36Manufacturing · Priority review	Approved	None posted
Sep 19, 1986	Supplement 33Manufacturing · Priority review	Approved	None posted
May 13, 1986	Supplement 32Manufacturing · Priority review	Approved	None posted
May 30, 1985	Supplement 30Manufacturing · Priority review	Approved	None posted
Jun 21, 1982	Supplement 29Labeling · Priority review	Approved	None posted
Feb 4, 1982	Supplement 28Manufacturing · Priority review	Approved	None posted
Sep 11, 1981	Supplement 26Manufacturing · Priority review	Approved	None posted
Jul 31, 1981	Supplement 25Manufacturing · Priority review	Approved	None posted
May 14, 1981	Supplement 24Manufacturing · Priority review	Approved	None posted
Mar 23, 1981	Supplement 22Manufacturing · Priority review	Approved	None posted
Jan 9, 1981	Supplement 21Labeling · Priority review	Approved	None posted
Jan 4, 1980	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 18, 1979	Supplement 19Labeling · Priority review	Approved	None posted
Dec 15, 1978	Supplement 16Manufacturing · Priority review	Approved	None posted
Dec 8, 1977	Supplement 15Manufacturing · Priority review	Approved	None posted
Mar 15, 1967	Original applicationNew active ingredient · Priority review	Approved	None posted

Identifiers

Application: NDA 16110
Drugs@FDA: Overview at FDA
Company: Apothecon

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