Clonazepam

As of Nov 14, 2026, ANDA 74940 (Clonazepam), held by Quagen, was first approved by FDA on Oct 30, 1997, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1997
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 30, 1997	Original application	Approved	Review

Products

3 strengths and forms


Clonazepam0.5MG · tablet;oral	Clonazepam	Discontinued
Clonazepam1MG · tablet;oral	Clonazepam	Discontinued
Clonazepam2MG · tablet;oral	Clonazepam	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Aug 28, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Nov 3, 2015	Supplement 6Labeling	Approved	None posted
Oct 15, 2009	Supplement 5Labeling	Approved	None posted
Feb 26, 2002	Supplement 3Labeling	Approved	None posted
Dec 15, 2000	Supplement 2Labeling	Approved	None posted
Oct 26, 1998	Supplement 1Labeling	Approved	None posted
Oct 30, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74940
Drugs@FDA: Overview at FDA
Company: Quagen Pharmaceuticals

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