Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017533
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KLONOPIN CLONAZEPAM 0.5MG TABLET;ORAL Prescription AB Yes No
KLONOPIN CLONAZEPAM 1MG TABLET;ORAL Prescription AB Yes Yes
KLONOPIN CLONAZEPAM 2MG TABLET;ORAL Prescription AB Yes No
KLONOPIN CLONAZEPAM 0.125MG TABLET;ORAL Discontinued None No No
KLONOPIN CLONAZEPAM 0.25MG TABLET;ORAL Discontinued None No 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
06/04/1975 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2017 SUPPL-59 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017533Orig1s059ltr.pdf
12/16/2016 SUPPL-58 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017533Orig1s058,020813Orig1s010ltr.pdf
11/02/2016 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

06/13/2016 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

03/25/2016 SUPPL-55 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017533Orig1s055ltr.pdf
02/03/2015 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

10/31/2013 SUPPL-53 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-52 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017533s052,020813s008ltr.pdf
09/01/2010 SUPPL-48 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-46 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-45 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
03/15/2002 SUPPL-39 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/11/2002 SUPPL-38 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/29/2002 SUPPL-37 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17533s37ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017533_S037_KLONOPIN_TABS_AP.pdf
11/07/2001 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/2001 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2001 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/28/2000 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1999 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/11/2001 SUPPL-31 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17533S31ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017533_S031_KLONOPIN_TABS_AP.pdf
12/30/1997 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/19/1997 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/07/1997 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/20/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/17/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/30/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/18/1996 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1997 SUPPL-23 Efficacy-New Indication

Label is not available on this site.

07/01/1994 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1993 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1993 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1993 SUPPL-19 Labeling

Label is not available on this site.

05/28/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/30/1993 SUPPL-17 Labeling

Label is not available on this site.

07/19/1990 SUPPL-16 Labeling

Label is not available on this site.

07/19/1990 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/01/1987 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1985 SUPPL-13 Labeling

Label is not available on this site.

12/11/1984 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1983 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/13/1981 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1980 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1981 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/19/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1979 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/30/1978 SUPPL-3 Labeling

Label is not available on this site.

06/30/1975 SUPPL-2 Labeling

Label is not available on this site.

09/26/1975 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2017 SUPPL-59 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf
10/25/2017 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf
12/16/2016 SUPPL-58 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf
12/16/2016 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf
03/25/2016 SUPPL-55 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf
03/25/2016 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf
10/31/2013 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf
09/01/2010 SUPPL-48 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
09/01/2010 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
09/01/2010 SUPPL-46 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf
04/23/2009 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf

KLONOPIN

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077147 ACCORD HLTHCARE
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 074869 ACTAVIS ELIZABETH
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 075150 MYLAN
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077856 PRINSTON INC
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 074979 SANDOZ
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 075423 SUN PHARM INDS INC
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 074569 TEVA
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 074964 WATSON LABS
KLONOPIN CLONAZEPAM 0.5MG TABLET;ORAL Prescription Yes AB 017533 ROCHE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 077147 ACCORD HLTHCARE
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 074869 ACTAVIS ELIZABETH
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 075150 MYLAN
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 077856 PRINSTON INC
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 074979 SANDOZ
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 075423 SUN PHARM INDS INC
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 074569 TEVA
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 074964 WATSON LABS
KLONOPIN CLONAZEPAM 1MG TABLET;ORAL Prescription Yes AB 017533 ROCHE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 077147 ACCORD HLTHCARE
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 074869 ACTAVIS ELIZABETH
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 075150 MYLAN
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 077856 PRINSTON INC
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 074979 SANDOZ
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 075423 SUN PHARM INDS INC
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 074569 TEVA
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 074964 WATSON LABS
KLONOPIN CLONAZEPAM 2MG TABLET;ORAL Prescription Yes AB 017533 ROCHE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English