Details for New Drug Application (NDA): 019174

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NDA 019174 describes TRANDATE HCT, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the TRANDATE HCT profile page.

The generic ingredient in TRANDATE HCT 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 019174

Tradename:	TRANDATE HCT
Applicant:	Glaxosmithkline
Ingredient:	hydrochlorothiazide; labetalol hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;100MG
Approval Date:	Apr 10, 1987	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;200MG
Approval Date:	Apr 10, 1987	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;300MG
Approval Date:	Apr 10, 1987	TE:		RLD:	No

Expired US Patents for NDA 019174

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-001	Apr 10, 1987	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-002	Apr 10, 1987	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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