Lygen

ANDA 85107, held by Alra. Chlordiazepoxide Hydrochloride.

As of Nov 15, 2026, ANDA 85107 (Lygen), held by Alra, was first approved by FDA on Apr 21, 1976, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 21, 1976
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
Apr 21, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lygen5MG · capsule;oral	Chlordiazepoxide Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


May 22, 1985	Supplement 14Manufacturing	Approved	None posted
Apr 21, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85107
Drugs@FDA: Overview at FDA
Company: ALRA

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