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Generated: November 12, 2018

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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 ActionAdrenergic beta-Antagonists
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:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 24, 1985TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Aug 1, 1984TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Aug 1, 1984TE:ABRLD:No

Expired US Patents for NDA 018716

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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