Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017533
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| 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| KLONOPIN | CLONAZEPAM | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| KLONOPIN | CLONAZEPAM | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017533s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017533Orig1s062ltr.pdf | |
| 02/05/2021 | SUPPL-61 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017533s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017533Orig1s061ltr.pdf | |
| 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-Package Insert, Labeling-Medication Guide |
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 | REMS-Proposal, Labeling |
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 |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017533s062lbl.pdf | |
| 02/05/2021 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017533s061lbl.pdf | |
| 02/05/2021 | SUPPL-61 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017533s061lbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf | |
| 12/16/2016 | SUPPL-58 | Labeling-Medication Guide | 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 | REMS-Proposal | 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 | |
| 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 | AUROBINDO PHARMA USA |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074925 | CHARTWELL RX |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 075468 | RUBICON RESEARCH |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | CHEPLAPHARM |
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 | AUROBINDO PHARMA USA |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074925 | CHARTWELL RX |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 075468 | RUBICON RESEARCH |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | CHEPLAPHARM |
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 | AUROBINDO PHARMA USA |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074925 | CHARTWELL RX |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 075468 | RUBICON RESEARCH |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | CHEPLAPHARM |