Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020813
Company: ROCHE
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RAPIDLY DISINTEGRATING CLONAZEPAM 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
KLONOPIN RAPIDLY DISINTEGRATING CLONAZEPAM 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
KLONOPIN RAPIDLY DISINTEGRATING CLONAZEPAM 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
KLONOPIN RAPIDLY DISINTEGRATING CLONAZEPAM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
KLONOPIN RAPIDLY DISINTEGRATING CLONAZEPAM 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None Yes No
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.

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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