Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Dow
McKinsey
Covington
Chinese Patent Office
Deloitte
Express Scripts
Boehringer Ingelheim
UBS
AstraZeneca

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019425

« Back to Dashboard

NDA 019425 describes TRANDATE, which is a drug marketed by Sebela Ireland Ltd, Cnty Line Pharms, and Glaxosmithkline, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the TRANDATE profile page.

The generic ingredient in TRANDATE is hydrochlorothiazide; labetalol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.
Summary for 019425
Tradename:TRANDATE
Applicant:Sebela Ireland Ltd
Ingredient:labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 31, 1985TE:RLD:Yes

Expired US Patents for NDA 019425

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd TRANDATE labetalol hydrochloride INJECTABLE;INJECTION 019425-001 Dec 31, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Sebela Ireland Ltd TRANDATE labetalol hydrochloride INJECTABLE;INJECTION 019425-001 Dec 31, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Julphar
US Army
Queensland Health
QuintilesIMS
Colorcon
Citi
UBS
Accenture

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.