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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 018687

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NDA 018687 describes NORMODYNE, which is a drug marketed by Schering and is included in two NDAs. Additional details are available on the NORMODYNE profile page.

The generic ingredient in NORMODYNE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for 018687

Tradename:	NORMODYNE
Applicant:	Schering
Ingredient:	labetalol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 018687

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DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	Aug 31, 1987	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DISCN	Dosage:	TABLET;ORAL			Strength	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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DISCN	Dosage:	TABLET;ORAL			Strength	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 018687

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984	⤷ Subscribe	⤷ Subscribe
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987	⤷ Subscribe	⤷ Subscribe
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-004	Aug 1, 1984	⤷ Subscribe	⤷ Subscribe
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984	⤷ Subscribe	⤷ Subscribe
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984	⤷ Subscribe	⤷ Subscribe
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984	⤷ Subscribe	⤷ Subscribe
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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