Details for New Drug Application (NDA): 019425

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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Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

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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	4,012,444	⤷ Subscribe
Sebela Ireland Ltd	TRANDATE	labetalol hydrochloride	INJECTABLE;INJECTION	019425-001	Dec 31, 1985	4,066,755	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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