Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017105
Company: RECORDATI RARE
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TRANXENE CLORAZEPATE DIPOTASSIUM 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
TRANXENE CLORAZEPATE DIPOTASSIUM 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
TRANXENE CLORAZEPATE DIPOTASSIUM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None No No
TRANXENE CLORAZEPATE DIPOTASSIUM 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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TRANXENE CLORAZEPATE DIPOTASSIUM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
TRANXENE SD CLORAZEPATE DIPOTASSIUM 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
TRANXENE SD CLORAZEPATE DIPOTASSIUM 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
06/23/1972 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
12/16/2016 SUPPL-79 Labeling-Package Insert, Labeling-Medication Guide 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
12/16/2016 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf
12/16/2016 SUPPL-79 Labeling-Medication Guide 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 MYLAN
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 075731 TARO
GEN-XENE CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 071788 ALRA
TRANXENE CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription Yes AB 017105 RECORDATI RARE

TRANXENE SD

There are no Therapeutic Equivalents.

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