TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (trandolapril)
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE is indicated for the treatment of Hypertension.
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 ) .
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
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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
Indications & Usage
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE is indicated for the treatment of Hypertension.
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.