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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 018716


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NDA 018716 describes TRANDATE, which is a drug marketed by Sebela Ireland Ltd, Alvogen, and Glaxosmithkline, and is included in three NDAs. 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:Alvogen
Ingredient:labetalol hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 24, 1985TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 1, 1984TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 1, 1984TE:RLD:Yes

Expired US Patents for NDA 018716

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

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