Details for New Drug Application (NDA): 018716

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NDA 018716 describes TRANDATE, which is a drug marketed by Sebela Ireland Ltd, Cnty Line Pharms, and Glaxosmithkline, and is included in three NDAs. It is available from seven suppliers. 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:	Cnty Line Pharms
Ingredient:	labetalol hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018716

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 018716

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

Suppliers and Packaging for NDA: 018716

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716	NDA	County Line Pharmaceuticals LLC	43199-037	43199-037-01	100 TABLET in 1 BOTTLE (43199-037-01)
TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716	NDA	County Line Pharmaceuticals LLC	43199-037	43199-037-05	500 TABLET in 1 BOTTLE (43199-037-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	May 24, 1985	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 1, 1984	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Aug 1, 1984	TE:	AB	RLD:	No

Expired US Patents for NDA 018716

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-004	Aug 1, 1984	➤ Sign Up	➤ Sign Up
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985	➤ Sign Up	➤ Sign Up
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	➤ Sign Up	➤ Sign Up
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984	➤ Sign Up	➤ Sign Up
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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