Klonopin Rapidly Disintegrating

NDA 20813, held by Roche. Clonazepam.

As of Nov 13, 2026, NDA 20813 (Klonopin Rapidly Disintegrating), held by Roche, was first approved by FDA on Dec 23, 1997, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1997
Review: Standard
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 23, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

5 strengths and forms


Klonopin Rapidly Disintegrating0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Clonazepam	DiscontinuedReference drug
Klonopin Rapidly Disintegrating0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Clonazepam	DiscontinuedReference drug
Klonopin Rapidly Disintegrating0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Clonazepam	DiscontinuedReference drug
Klonopin Rapidly Disintegrating1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Clonazepam	DiscontinuedReference drug
Klonopin Rapidly Disintegrating2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Clonazepam	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Dec 16, 2016	Supplement 10Labeling · Standard review	Approved	Medication Guide Letter Label
Oct 31, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Nov 29, 2011	Supplement 8REMS	Approved	Letter
Sep 1, 2010	Supplement 6Labeling · Standard review	Approved	Letter Label
Sep 1, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Apr 23, 2009	Supplement 5Labeling	Approved	Label Letter
Dec 3, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 31, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 23, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20813
Drugs@FDA: Overview at FDA
Company: Roche

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