Lomotil

Manages diarrhea. NDA 12462, held by Pfizer. Atropine Sulfate; Diphenoxylate Hydrochloride.

As of Nov 14, 2026, NDA 12462 (Lomotil), held by Pfizer, was first approved by FDA on Sep 15, 1960, with 19 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1960
Review: Priority
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Diphenoxylate hydrochloride is effective as adjunctive therapy in the management of diarrhea.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Sep 15, 1960	Original applicationNew combination · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lomotil0.025MG;2.5MG · tablet;oral	Atropine Sulfate; Diphenoxylate Hydrochloride	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Feb 12, 2018	Supplement 48Labeling · Standard review	Approved	Label Letter
Oct 5, 2017	Supplement 45Labeling · Standard review	Approved	Label Letter
Apr 28, 2006	Supplement 42Labeling · Standard review	Approved	Letter
Jun 7, 1996	Supplement 41Manufacturing · Priority review	Approved	None posted
Feb 18, 1994	Supplement 40Labeling · Standard review	Approved	None posted
Apr 23, 1991	Supplement 39Labeling	Approved	None posted
Mar 12, 1987	Supplement 38Labeling	Approved	None posted
Jun 4, 1986	Supplement 37Manufacturing · Priority review	Approved	None posted
Apr 7, 1986	Supplement 36Labeling	Approved	None posted
Mar 1, 1984	Supplement 35Labeling	Approved	None posted
Dec 21, 1983	Supplement 34Labeling	Approved	None posted
Apr 7, 1983	Supplement 33Manufacturing · Priority review	Approved	None posted
Mar 4, 1982	Supplement 31Labeling	Approved	None posted
Jan 8, 1981	Supplement 29Manufacturing · Priority review	Approved	None posted
Dec 30, 1980	Supplement 30Manufacturing · Priority review	Approved	None posted
Nov 5, 1979	Supplement 27Labeling	Approved	None posted
Feb 22, 1979	Supplement 28Labeling	Approved	None posted
Feb 28, 1977	Supplement 25Manufacturing · Priority review	Approved	None posted
Feb 28, 1977	Supplement 26Labeling	Approved	None posted
Sep 15, 1960	Original applicationNew combination · Priority review	Approved	None posted

Identifiers

Application: NDA 12462
Drugs@FDA: Overview at FDA
Company: Pfizer

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