Details for New Drug Application (NDA): 019425

✉ Email this page to a colleague

NDA 019425 describes TRANDATE, which is a drug marketed by Sebela Ireland Ltd, Alvogen, and Glaxosmithkline, and is included in three NDAs. 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

Medical Subject Heading (MeSH) Categories for 019425

Adrenergic alpha-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Sympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 31, 1985	TE:		RLD:	Yes

Expired US Patents for NDA 019425

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	TRANDATE	labetalol hydrochloride	INJECTABLE;INJECTION	019425-001	Dec 31, 1985	⤷ Sign Up	⤷ Sign Up
>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

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 verification 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.