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Covington
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US Department of Justice
Fuji
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Medtronic
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017105

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NDA 017105 describes TRANXENE SD, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. 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. Nine suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.
Summary for 017105
Tradename:TRANXENE SD
Applicant:Recordati Rare
Ingredient:clorazepate dipotassium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017105
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 017105
Suppliers and Packaging for NDA: 017105
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANXENE clorazepate dipotassium CAPSULE;ORAL 017105 NDA RECORDATI RARE DISEASES, INC. 55292-302 N 55292-302-01
TRANXENE clorazepate dipotassium TABLET;ORAL 017105 NDA RECORDATI RARE DISEASES, INC. 55292-302 N 55292-302-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength3.75MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength7.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired US Patents for NDA 017105

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recordati Rare TRANXENE clorazepate dipotassium CAPSULE;ORAL 017105-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Recordati Rare TRANXENE clorazepate dipotassium TABLET;ORAL 017105-006 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Recordati Rare TRANXENE clorazepate dipotassium TABLET;ORAL 017105-007 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Recordati Rare TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-005 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Recordati Rare TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-004 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Recordati Rare TRANXENE clorazepate dipotassium TABLET;ORAL 017105-008 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Recordati Rare TRANXENE clorazepate dipotassium CAPSULE;ORAL 017105-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Recordati Rare TRANXENE clorazepate dipotassium CAPSULE;ORAL 017105-003 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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