TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 2010-05-05
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE Approval History
What TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE Treats
1 indicationsTRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE Boxed Warning
FETAL TOXICITY • When pregnancy is detected, discontinue trandolapril and verapamil hydrochloride extended-release tablets 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 trandolapril and verapamil hydrochloride extended-release tablets 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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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.
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Trandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using trandolapril and verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have si...
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue trandolapril and verapamil hydrochloride extended-release tablets 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.