Prolixin Decanoate

NDA 16727, held by Bristol Myers Squibb. Fluphenazine Decanoate.

As of Nov 13, 2026, NDA 16727 (Prolixin Decanoate), held by Bristol Myers Squibb, was first approved by FDA on Jun 20, 1972, with 41 approved supplements and 0 published complete response letters.

First approved: Jun 20, 1972
Review: Standard
Supplements approved: 41
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 42 submissions below

Date	Submission	Status	Documents
Jun 20, 1972	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prolixin Decanoate25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Fluphenazine Decanoate	DiscontinuedReference drug

All 42 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 46Labeling	Approved	None posted
Mar 13, 2009	Supplement 45Labeling	Approved	None posted
Mar 13, 2009	Supplement 41Labeling	Approved	None posted
Mar 13, 2009	Supplement 40Labeling	Approved	None posted
Mar 13, 2009	Supplement 38Labeling	Approved	None posted
Mar 13, 2009	Supplement 35Labeling	Approved	None posted
Mar 13, 2009	Supplement 23Labeling	Approved	None posted
Mar 13, 2009	Supplement 14Labeling	Approved	None posted
Mar 13, 2009	Supplement 11Labeling	Approved	None posted
Mar 13, 2009	Supplement 8Labeling	Approved	None posted
Mar 13, 2009	Supplement 6Labeling	Approved	None posted
Oct 4, 2002	Supplement 53Manufacturing · Standard review	Approved	None posted
Sep 17, 2001	Supplement 52Manufacturing · Standard review	Approved	None posted
Feb 15, 1996	Supplement 49Manufacturing · Standard review	Approved	None posted
Aug 16, 1994	Supplement 51Manufacturing · Standard review	Approved	None posted
Aug 11, 1994	Supplement 50Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 48Manufacturing · Standard review	Approved	None posted
Jun 15, 1987	Supplement 43Manufacturing · Standard review	Approved	None posted
Jun 15, 1987	Supplement 42Manufacturing · Standard review	Approved	None posted
Sep 19, 1986	Supplement 39Manufacturing · Standard review	Approved	None posted
Oct 23, 1985	Supplement 37Manufacturing · Standard review	Approved	None posted
May 30, 1985	Supplement 30Manufacturing · Standard review	Approved	None posted
Feb 12, 1985	Supplement 36Manufacturing · Standard review	Approved	None posted
Dec 21, 1984	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 29, 1984	Supplement 34Labeling	Approved	None posted
May 11, 1984	Supplement 32Manufacturing · Standard review	Approved	None posted
May 3, 1983	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 4, 1982	Supplement 28Labeling	Approved	None posted
Aug 4, 1982	Supplement 27Labeling	Approved	None posted
Feb 4, 1982	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 10, 1981	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 16, 1981	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 23, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 9, 1981	Supplement 20Labeling	Approved	None posted
Apr 28, 1980	Supplement 19Labeling	Approved	None posted
Jan 4, 1980	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 20, 1979	Supplement 17Labeling	Approved	None posted
Dec 20, 1979	Supplement 16Labeling	Approved	None posted
Feb 6, 1979	Supplement 10Labeling	Approved	None posted
Nov 21, 1978	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 25, 1974	Supplement 4	Approved	None posted
Jun 20, 1972	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 16727
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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