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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 019174


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NDA 019174 describes TRANDATE HCT, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the TRANDATE HCT profile page.

The generic ingredient in TRANDATE HCT 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 019174

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Apr 10, 1987TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;200MG
Approval Date:Apr 10, 1987TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;300MG
Approval Date:Apr 10, 1987TE:RLD:No

Expired US Patents for NDA 019174

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-002 Apr 10, 1987 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-001 Apr 10, 1987 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline TRANDATE HCT hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019174-004 Apr 10, 1987 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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