Details for New Drug Application (NDA): 018716

« Back to Dashboard

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 eight 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:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 1, 1984	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Aug 1, 1984	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018716

Subscribe to access the full database, or try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-001	May 24, 1985	➤ Try a Free Trial	➤ Try a Free Trial
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-003	Aug 1, 1984	➤ Try a Free Trial	➤ Try a Free Trial
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-002	Aug 1, 1984	➤ Try a Free Trial	➤ Try a Free Trial
Cnty Line Pharms	TRANDATE	labetalol hydrochloride	TABLET;ORAL	018716-004	Aug 1, 1984	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.