FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (fosinopril sodium)
Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. (See DOSAGE AND ADMINISTRATION . ) In using fosinopril sodium and hydrochlorothiazide, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease.
Details
- Status
- Discontinued
- First Approved
- 2004-12-03
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE Approval History
What FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE Treats
8 FDA approvalsOriginally approved for its first indication in 2004 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Dec 2004)Letter
- • Approved indication (Dec 2004)
- • Approved indication (Aug 2005)
- • Approved indication (Sep 2005)
- • Approved indication (Jul 2006)
- • Approved indication (Aug 2006)
- • Approved indication (Jul 2009)
- • Approved indication (Sep 2010)
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue fosinopril and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue fosinopril and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FDA Label Details
Indications & Usage
Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION . ) In using fosinopril sodium and hydrochlorothiazide, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis ). AC...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue fosinopril and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.