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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-one drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.

Summary for NDA: 019046

Tradename:
NORMOZIDE
Applicant:
Schering
Ingredient:
hydrochlorothiazide; labetalol hydrochloride
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 019046

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering
NORMOZIDE
hydrochlorothiazide; labetalol hydrochloride
TABLET;ORAL019046-001Apr 6, 19874,012,444► subscribe
Schering
NORMOZIDE
hydrochlorothiazide; labetalol hydrochloride
TABLET;ORAL019046-003Apr 6, 19874,012,444► subscribe
Schering
NORMOZIDE
hydrochlorothiazide; labetalol hydrochloride
TABLET;ORAL019046-004Apr 6, 19874,012,444► subscribe
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