Clonazepam

ANDA 74964, held by Watson Labs. Clonazepam.

As of Nov 14, 2026, ANDA 74964 (Clonazepam), held by Watson Labs, was first approved by FDA on Dec 30, 1997, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1997
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 30, 1997	Original application	Approved	None posted

Products

3 strengths and forms


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

All 9 submissions, including labeling and manufacturing supplements


Nov 5, 2015	Supplement 18Labeling	Approved	None posted
Oct 15, 2009	Supplement 15Labeling	Approved	None posted
Oct 20, 2004	Supplement 7Labeling	Approved	None posted
Oct 28, 2003	Supplement 5Labeling	Approved	None posted
Apr 12, 2001	Supplement 3Manufacturing	Approved	None posted
Dec 22, 2000	Supplement 4Labeling	Approved	None posted
Mar 21, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 21, 1998	Supplement 1Manufacturing	Approved	None posted
Dec 30, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74964
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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