Clonazepam

As of Nov 14, 2026, ANDA 74979 (Clonazepam), held by Sandoz, was first approved by FDA on Aug 29, 1997, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 29, 1997
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 29, 1997	Original application	Approved	Review

Products

3 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


Apr 23, 2018	Supplement 25Manufacturing	Approved	None posted
Jul 31, 2017	Supplement 23Labeling · Standard review	Approved	None posted
Jul 18, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Oct 23, 2012	Supplement 15Labeling · Standard review	Approved	None posted
Mar 30, 2011	Supplement 13Labeling	Approved	None posted
Mar 30, 2011	Supplement 14Labeling	Approved	None posted
Feb 23, 2010	Supplement 12Labeling	Approved	None posted
Oct 18, 2000	Supplement 3Labeling	Approved	None posted
Feb 2, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 29, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74979
Drugs@FDA: Overview at FDA
Company: Sandoz

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