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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017105
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TRANXENE CLORAZEPATE DIPOTASSIUM 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
TRANXENE CLORAZEPATE DIPOTASSIUM 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
TRANXENE CLORAZEPATE DIPOTASSIUM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
TRANXENE CLORAZEPATE DIPOTASSIUM 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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TRANXENE CLORAZEPATE DIPOTASSIUM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
TRANXENE SD CLORAZEPATE DIPOTASSIUM 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
TRANXENE SD CLORAZEPATE DIPOTASSIUM 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
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
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