Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Harvard Business School
Johnson and Johnson
Mallinckrodt
Merck

Last Updated: November 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017105

See Plans and Pricing

« Back to Dashboard

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. Four 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
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. 55292-304 55292-304-01 100 TABLET in 1 BOTTLE (55292-304-01)
TRANXENE clorazepate dipotassium TABLET;ORAL 017105 NDA RECORDATI RARE DISEASES, INC. 55292-304 55292-304-01 100 TABLET in 1 BOTTLE (55292-304-01)

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
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   Start Trial   Start Trial
Recordati Rare TRANXENE clorazepate dipotassium TABLET;ORAL 017105-006 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Recordati Rare TRANXENE clorazepate dipotassium TABLET;ORAL 017105-007 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Recordati Rare TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Recordati Rare TRANXENE SD clorazepate dipotassium TABLET;ORAL 017105-005 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Recordati Rare TRANXENE clorazepate dipotassium TABLET;ORAL 017105-008 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Express Scripts
Merck
Colorcon
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.