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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 019046

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NDA 019046 describes NORMOZIDE, which is a drug marketed by Schering and is included in one NDA. Additional details are available on the NORMOZIDE profile page.

The generic ingredient in NORMOZIDE 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 019046

Tradename:	NORMOZIDE
Applicant:	Schering
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 6, 1987	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;200MG
Approval Date:	Apr 6, 1987	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;300MG
Approval Date:	Apr 6, 1987	TE:		RLD:	No

Expired US Patents for NDA 019046

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987	⤷ Get Started Free	⤷ Get Started Free
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987	⤷ Get Started Free	⤷ Get Started Free
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-004	Apr 6, 1987	⤷ Get Started Free	⤷ Get Started Free
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987	⤷ Get Started Free	⤷ Get Started Free
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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