Prolixin

NDA 11751, held by Apothecon. Fluphenazine Hydrochloride.

As of Nov 14, 2026, NDA 11751 (Prolixin), held by Apothecon, was first approved by FDA on Aug 24, 1960, with 36 approved supplements and 0 published complete response letters.

First approved: Aug 24, 1960
Review: Standard
Supplements approved: 36
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below

Date	Submission	Status	Documents
Aug 24, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

5 strengths and forms


Prolixin2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fluphenazine Hydrochloride	DiscontinuedReference drug
Prolixin10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fluphenazine Hydrochloride	DiscontinuedReference drug
Prolixin5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fluphenazine Hydrochloride	DiscontinuedReference drug
Prolixin1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fluphenazine Hydrochloride	DiscontinuedReference drug
Prolixin2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Fluphenazine Hydrochloride	Discontinued

All 37 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 90Labeling	Approved	None posted
Mar 13, 2009	Supplement 89Labeling	Approved	None posted
Mar 13, 2009	Supplement 88Labeling	Approved	None posted
Mar 13, 2009	Supplement 87Labeling	Approved	None posted
Mar 13, 2009	Supplement 84Labeling	Approved	None posted
Mar 13, 2009	Supplement 82Labeling	Approved	None posted
Mar 13, 2009	Supplement 77Labeling	Approved	None posted
Mar 13, 2009	Supplement 76Labeling	Approved	None posted
Mar 13, 2009	Supplement 65Labeling	Approved	None posted
Mar 13, 2009	Supplement 64Labeling	Approved	None posted
Mar 13, 2009	Supplement 61Labeling	Approved	None posted
Mar 13, 2009	Supplement 59Labeling	Approved	None posted
Mar 13, 2009	Supplement 58Labeling	Approved	None posted
Mar 13, 2009	Supplement 56Labeling	Approved	None posted
Mar 13, 2009	Supplement 55Labeling	Approved	None posted
Mar 13, 2009	Supplement 54Labeling	Approved	None posted
Mar 13, 2009	Supplement 49Labeling	Approved	None posted
Mar 13, 2009	Supplement 48Labeling	Approved	None posted
Mar 13, 2009	Supplement 46Labeling	Approved	None posted
Mar 13, 2009	Supplement 45Labeling	Approved	None posted
Mar 13, 2009	Supplement 30Labeling	Approved	None posted
Mar 13, 2009	Supplement 29Labeling	Approved	None posted
Mar 13, 2009	Supplement 28Labeling	Approved	None posted
Mar 13, 2009	Supplement 27Labeling	Approved	None posted
Mar 13, 2009	Supplement 25Labeling	Approved	None posted
Mar 13, 2009	Supplement 23Labeling	Approved	None posted
Sep 30, 2002	Supplement 99Manufacturing · Standard review	Approved	None posted
Aug 8, 1997	Supplement 98Manufacturing · Standard review	Approved	None posted
Aug 8, 1997	Supplement 97Manufacturing · Standard review	Approved	None posted
May 30, 1997	Supplement 95Labeling · Standard review	Approved	None posted
Dec 20, 1994	Supplement 93Labeling · Standard review	Approved	None posted
Jun 28, 1991	Supplement 92Labeling	Approved	None posted
Jun 28, 1991	Supplement 91Manufacturing · Standard review	Approved	None posted
Aug 2, 1985	Supplement 79Manufacturing · Standard review	Approved	None posted
Apr 23, 1979	Supplement 52Labeling	Approved	None posted
Feb 6, 1979	Supplement 47Labeling	Approved	None posted
Aug 24, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 11751
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