Details for New Drug Application (NDA): 018686

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NDA 018686 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 018686

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

Medical Subject Heading (MeSH) Categories for 018686

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Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	Aug 1, 1984	TE:		RLD:	Yes

Expired US Patents for NDA 018686

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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