Motofen Half-Strength, Motofen

Manages acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea. NDA 17744, held by Legacy. Atropine Sulfate; Difenoxin Hydrochloride.

As of Nov 13, 2026, NDA 17744 (Motofen Half-Strength, Motofen), held by Legacy, was first approved by FDA on Jul 14, 1978, with 21 approved supplements and 0 published complete response letters.

First approved: Jul 14, 1978
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE MOTOFEN is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Jul 14, 1978	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Motofen Half-Strength0.025MG;0.5MG · tablet;oral	Atropine Sulfate; Difenoxin Hydrochloride	Discontinued
Motofen0.025MG;1MG · tablet;oral	Atropine Sulfate; Difenoxin Hydrochloride	RxReference drug

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 28, 2017	Supplement 26Labeling · Standard review	Approved	Label Letter
Dec 17, 2001	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 17, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
May 25, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 3, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 7, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 7, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 8, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 13, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 27, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 19, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 29, 1992	Supplement 10Labeling	Approved	None posted
Dec 3, 1991	Supplement 5Labeling	Approved	None posted
Jan 29, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 19, 1988	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 20, 1988	Supplement 3Labeling	Approved	None posted
Apr 21, 1982	Supplement 2Labeling	Approved	None posted
Dec 28, 1981	Supplement 1Labeling	Approved	None posted
Jul 14, 1978	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Identifiers

Application: NDA 17744
Drugs@FDA: Overview at FDA
Company: LEGACY

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