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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 017105


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NDA 017105 describes TRANXENE SD, which is a drug marketed by Ajenat Pharms and is included in one NDA. Additional details are available on the TRANXENE SD profile page.

The generic ingredient in TRANXENE SD is clorazepate dipotassium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.
Summary for 017105
Tradename:TRANXENE SD
Applicant:Ajenat Pharms
Ingredient:clorazepate dipotassium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 017105

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 017105

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ajenat Pharms TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-005 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Ajenat Pharms TRANXENE clorazepate dipotassium CAPSULE;ORAL 017105-003 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Ajenat Pharms TRANXENE clorazepate dipotassium TABLET;ORAL 017105-006 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Ajenat Pharms TRANXENE clorazepate dipotassium CAPSULE;ORAL 017105-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Ajenat Pharms TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-004 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Ajenat Pharms TRANXENE clorazepate dipotassium TABLET;ORAL 017105-008 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Ajenat Pharms TRANXENE clorazepate dipotassium TABLET;ORAL 017105-007 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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