GRANISETRON HYDROCHLORIDE · Dr. Reddy's
Granisetron hydrochloride tablets are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
Details
- Status
- Prescription
- First Approved
- 1993-12-29
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET, SOLUTION
Companies
GRANISETRON HYDROCHLORIDE Approval History
What GRANISETRON HYDROCHLORIDE Treats
2 indicationsGRANISETRON HYDROCHLORIDE is approved for 2 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
GRANISETRON 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.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03924518 GRANTISS | 2018-ZZJHZX-009 | Ph 2 | completed | Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock |
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.
GRANISETRON HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Granisetron hydrochloride tablets are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.