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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019425

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

The generic ingredient in TRANDATE is hydrochlorothiazide; labetalol hydrochloride. There are thirty-one drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.

Summary for NDA: 019425

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 019425

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
TRANDATE
labetalol hydrochloride
INJECTABLE;INJECTION019425-001Dec 31, 19854,012,444► Subscribe
Sebela Ireland Ltd
TRANDATE
labetalol hydrochloride
INJECTABLE;INJECTION019425-001Dec 31, 19854,066,755► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKinsey
Fish and Richardson
US Army
US Department of Justice
Dow
Fuji
AstraZeneca
QuintilesIMS
Boehringer Ingelheim
Cipla

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.

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