Clonazepam

ANDA 75423, held by Sun Pharm Inds Inc. Clonazepam.

As of Nov 14, 2026, ANDA 75423 (Clonazepam), held by Sun Pharm Inds Inc, was first approved by FDA on Apr 27, 2001, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2001
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
Apr 27, 2001	Original application	Approved	Letter

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


Jun 20, 2012	Supplement 19Labeling · Standard review	Approved	None posted
Apr 8, 2011	Supplement 14Labeling	Approved	None posted
Apr 8, 2011	Supplement 15REMS	Approved	None posted
Nov 2, 2009	Supplement 13Labeling	Approved	None posted
Sep 15, 2005	Supplement 6Labeling	Approved	None posted
Feb 20, 2003	Supplement 2Labeling	Approved	None posted
Apr 27, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75423
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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