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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020813
Company: ROCHE

Medication Guide

Products on NDA 020813

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KLONOPIN RAPIDLY DISINTEGRATING	CLONAZEPAM	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
KLONOPIN RAPIDLY DISINTEGRATING	CLONAZEPAM	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
KLONOPIN RAPIDLY DISINTEGRATING	CLONAZEPAM	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
KLONOPIN RAPIDLY DISINTEGRATING	CLONAZEPAM	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No
KLONOPIN RAPIDLY DISINTEGRATING	CLONAZEPAM	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2016	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020813s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017533Orig1s058,020813Orig1s010ltr.pdf
10/31/2013	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017533Orig1s053,020813Orig1s009ltr.pdf
11/29/2011	SUPPL-8	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017533s046,020813s008ltr.pdf
09/01/2010	SUPPL-7	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf
09/01/2010	SUPPL-6	Labeling, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf
04/23/2009	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017533s045,020813s005ltr.pdf
12/03/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/31/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020813

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2016	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020813s010lbl.pdf
12/16/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020813s010lbl.pdf
10/31/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf
09/01/2010	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
09/01/2010	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
09/01/2010	SUPPL-6	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
04/23/2009	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf

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