Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017105
Company: KEY THERAP
Company: KEY THERAP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRANXENE | CLORAZEPATE DIPOTASSIUM | 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| TRANXENE | CLORAZEPATE DIPOTASSIUM | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| TRANXENE | CLORAZEPATE DIPOTASSIUM | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| TRANXENE | CLORAZEPATE DIPOTASSIUM | 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TRANXENE | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TRANXENE | CLORAZEPATE DIPOTASSIUM | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TRANXENE SD | CLORAZEPATE DIPOTASSIUM | 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| TRANXENE SD | CLORAZEPATE DIPOTASSIUM | 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/23/1972 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-85 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017105Orig1s085ltr.pdf | |
| 02/05/2021 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017105s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017105Orig1s084ltr.pdf | |
| 12/16/2016 | SUPPL-79 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017105Orig1s079ltr.pdf | |
| 02/03/2015 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/2011 | SUPPL-77 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017105s077ltr.pdf |
| 06/07/2010 | SUPPL-76 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017105s076ltr.pdf | |
| 04/23/2009 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017105s075ltr.pdf | |
| 03/13/2003 | SUPPL-70 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17105slr070ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017105_S070_Tranxene_APPROVAL_PACKAGE.pdf |
| 08/28/2002 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-68 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/04/1999 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1996 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1988 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-62 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S062_TRANXENE_AP.pdf |
| 11/05/1987 | SUPPL-60 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/07/2002 | SUPPL-59 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S059_TRANXENE_AP.pdf |
| 08/13/1987 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1987 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1986 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1986 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1985 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1986 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1984 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1980 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1980 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/14/1980 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 12/12/1979 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 01/29/1981 | SUPPL-39 | Efficacy |
Label is not available on this site. |
||
| 05/31/1979 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/1979 | SUPPL-37 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/07/1979 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1979 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1979 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1978 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/17/1978 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/05/1978 | SUPPL-31 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/21/1977 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/09/1979 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1977 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/21/1976 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/1977 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1976 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1980 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1976 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/18/1977 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1976 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1976 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/04/1976 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1975 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1975 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/13/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1975 | SUPPL-8 | 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-85 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf | |
| 01/13/2023 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf | |
| 02/05/2021 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017105s084lbl.pdf | |
| 12/16/2016 | SUPPL-79 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf | |
| 12/16/2016 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf | |
| 06/07/2010 | SUPPL-76 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf | |
| 06/07/2010 | SUPPL-76 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf | |
| 04/23/2009 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf |
TRANXENE
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 071858 | AUROBINDO PHARMA |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 215566 | COREPHARMA |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 213730 | NOVITIUM PHARMA |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 075731 | TARO |
| TRANXENE | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | Yes | AB | 017105 | KEY THERAP |
TRANXENE SD
There are no Therapeutic Equivalents.