Leritine

NDA 10585, held by Merck. Anileridine Hydrochloride.

As of Nov 13, 2026, NDA 10585 (Leritine), held by Merck, was first approved by FDA on Aug 15, 1957, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 15, 1957
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 15, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
LeritineEQ 25MG BASE · tablet;oral	Anileridine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 18, 1978	Supplement 10Labeling	Approved	None posted
Nov 24, 1975	Supplement 8Labeling	Approved	None posted
Mar 31, 1975	Supplement 7Labeling	Approved	None posted
Aug 15, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10585
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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