Orgatrax

ANDA 87014, held by Organon USA Inc. Hydroxyzine Hydrochloride.

As of Nov 15, 2026, ANDA 87014 (Orgatrax), held by Organon USA Inc, was first approved by FDA on Jun 27, 1980, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 27, 1980
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 27, 1980	Original application	Approved	Other

Products

2 strengths and forms


Orgatrax25MG/ML · injectable;injection	Hydroxyzine Hydrochloride	Discontinued
Orgatrax50MG/ML · injectable;injection	Hydroxyzine Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 28, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Jun 26, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Jul 23, 1982	Supplement 4Manufacturing	Approved	None posted
Jul 23, 1982	Supplement 3Manufacturing	Approved	None posted
Jun 27, 1980	Original application	Approved	Other

Identifiers

Application: ANDA 87014
Drugs@FDA: Overview at FDA
Company: Organon USA

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