Largon

NDA 12382, held by Hikma. Propiomazine Hydrochloride.

As of Nov 13, 2026, NDA 12382 (Largon), held by Hikma, was first approved by FDA on Dec 5, 1960, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 5, 1960
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 5, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Largon20MG/ML · injectable;injection	Propiomazine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 5, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 5, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12382
Drugs@FDA: Overview at FDA
Company: Hikma

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