Serentil

NDA 16997, held by Novartis. Mesoridazine Besylate.

As of Nov 14, 2026, NDA 16997 (Serentil), held by Novartis, was first approved by FDA on Jan 31, 1972, with 28 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1972
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
Jan 31, 1972	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
SerentilEQ 25MG BASE/ML · concentrate;oral	Mesoridazine Besylate	Discontinued

All 29 submissions, including labeling and manufacturing supplements


Mar 15, 2001	Supplement 41Labeling · Standard review	Approved	Review Letter
Sep 6, 2000	Supplement 40Labeling · Standard review	Approved	None posted
Mar 14, 1997	Supplement 39Manufacturing · Standard review	Approved	None posted
Jan 25, 1991	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 15, 1989	Supplement 32Manufacturing · Standard review	Approved	None posted
May 10, 1989	Supplement 31Manufacturing · Standard review	Approved	None posted
Aug 20, 1987	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 9, 1987	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 9, 1987	Supplement 25Manufacturing · Standard review	Approved	None posted
May 26, 1987	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 23, 1987	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 28, 1987	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 24, 1986	Supplement 22Manufacturing · Standard review	Approved	None posted
Nov 24, 1986	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 24, 1986	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 24, 1986	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 10, 1986	Supplement 18Manufacturing · Standard review	Approved	None posted
May 29, 1984	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 5, 1982	Supplement 14Labeling · Standard review	Approved	None posted
Sep 13, 1982	Supplement 13Manufacturing · Standard review	Approved	None posted
May 14, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 10, 1980	Supplement 10Labeling · Standard review	Approved	None posted
May 13, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 16, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
May 25, 1976	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 2, 1975	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 31, 1975	Supplement 5Labeling · Standard review	Approved	None posted
Mar 31, 1975	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 31, 1972	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16997
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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