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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 018716

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NDA 018716 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 018716

Tradename:	TRANDATE
Applicant:	Alvogen
Ingredient:	labetalol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 018716

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 24, 1985	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 1, 1984	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 1, 1984	TE:		RLD:	Yes

Expired US Patents for NDA 018716

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984	⤷ Get Started Free	⤷ Get Started Free
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985	⤷ Get Started Free	⤷ Get Started Free
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-004	Aug 1, 1984	⤷ Get Started Free	⤷ Get Started Free
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984	⤷ Get Started Free	⤷ Get Started Free
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	⤷ Get Started Free	⤷ Get Started Free
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	⤷ Get Started Free	⤷ Get Started Free
Alvogen	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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