APPLICATION
NDA019046
TYPE
NDA
ORIGINAL APPROVAL
1987-04-06
LATEST ACTION
1990-11-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORMOZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LABETALOL HYDROCHLORIDE 400MG · TABLET · ORAL
NORMOZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LABETALOL HYDROCHLORIDE 200MG · TABLET · ORAL
NORMOZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LABETALOL HYDROCHLORIDE 300MG · TABLET · ORAL
NORMOZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LABETALOL HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
1990-11-07Labeling · Supplement 7AP
1989-06-16Labeling · Supplement 6AP
1989-06-16Labeling · Supplement 4AP
1988-04-14Labeling · Supplement 2AP
1987-04-06Type 4 - New Combination · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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