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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 019046


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NDA 019046 describes NORMOZIDE, which is a drug marketed by Schering and is included in one NDA. Additional details are available on the NORMOZIDE profile page.

The generic ingredient in NORMOZIDE 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 019046
Tradename:NORMOZIDE
Applicant:Schering
Ingredient:hydrochlorothiazide; labetalol hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Apr 6, 1987TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;200MG
Approval Date:Apr 6, 1987TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG;300MG
Approval Date:Apr 6, 1987TE:RLD:No

Expired US Patents for NDA 019046

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering NORMOZIDE hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019046-001 Apr 6, 1987 ⤷  Sign Up ⤷  Sign Up
Schering NORMOZIDE hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019046-002 Apr 6, 1987 ⤷  Sign Up ⤷  Sign Up
Schering NORMOZIDE hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019046-003 Apr 6, 1987 ⤷  Sign Up ⤷  Sign Up
Schering NORMOZIDE hydrochlorothiazide; labetalol hydrochloride TABLET;ORAL 019046-004 Apr 6, 1987 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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