APPLICATION
NDA011835
TYPE
NDA
ORIGINAL APPROVAL
1959-02-24
LATEST ACTION
2002-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDRODIURIL · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HYDRODIURIL · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
HYDRODIURIL · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-01-10Manufacturing (CMC) · Supplement 64 · standardAP
1998-11-05Labeling · Supplement 60 · standardAP
1997-09-09Manufacturing (CMC) · Supplement 61 · standardAP
1997-09-08Manufacturing (CMC) · Supplement 62 · standardAP
1996-02-08Manufacturing (CMC) · Supplement 59 · standardAP
1995-11-29Manufacturing (CMC) · Supplement 58 · standardAP
1994-09-26Manufacturing (CMC) · Supplement 57 · standardAP
1994-06-29Labeling · Supplement 55 · standardAP
1994-02-16Labeling · Supplement 56 · standardAP
1992-10-28Efficacy · Supplement 44 · standardAP
1992-10-28Labeling · Supplement 53 · standardAP
1992-10-28Labeling · Supplement 51 · standardAP
1959-02-24Type 5 - New Formulation or New Manufacturer · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.