Moban

NDA 17938, held by Endo Pharms. Molindone Hydrochloride.

As of Nov 14, 2026, NDA 17938 (Moban), held by Endo Pharms, was first approved by FDA on Dec 28, 1979, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1979
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 28, 1979	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Moban20MG/ML · concentrate;oral	Molindone Hydrochloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Jan 15, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
May 22, 2001	Supplement 22Labeling · Standard review	Approved	Letter
Aug 21, 1998	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 25, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 28, 1995	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 28, 1995	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 28, 1995	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 21, 1984	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 19, 1982	Supplement 7Labeling · Standard review	Approved	None posted
Nov 16, 1981	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 24, 1981	Supplement 3Labeling · Standard review	Approved	None posted
Jan 5, 1981	Supplement 2Labeling · Standard review	Approved	None posted
Dec 28, 1979	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17938
Drugs@FDA: Overview at FDA
Company: Endo Pharmaceuticals

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